Public procurement
21053967
Lot nr. 1 Bandaj (Fase) de tifon, 5m x 10cm, nesterila, densitatea min 32g/m2
1
Enquiry period
with 25.03.2022 18:14
to 06.04.2022 17:37
to 06.04.2022 17:37
2
Bidding period
with 06.04.2022 17:37
to 14.04.2022 17:37
to 14.04.2022 17:37
3
Auction
4
Evaluation
5
Bids have been evaluated
Status
Bids have been evaluated
Estimated value without VAT
1 132 406,35 MDL
Period of clarifications:
25 Mar 2022, 18:14 - 6 Apr 2022, 17:37
Submission of proposals:
6 Apr 2022, 17:37 - 14 Apr 2022, 17:37
Auction start date:
will not be used
Supplier technical support:
(+373) 79999801
This procedure is carried out without auction. Your offer is final and must contain the entire list of required documents.
Lot nr. 1 Lot nr. 1 Bandaj (Fase) de tifon, 5m x 10cm, nesterila, densitatea min 32g/m2
Information about customer
Fiscal code/IDNO
Address
MD-2009, MOLDOVA, mun.Chişinău, mun.Chişinău, MD-2009, Republica Moldova, Chişinău str. Cosmescu 3
Web site
---
The contact person
Purchase data
Date created
25 Mar 2022, 18:10
Date modified
4 Apr 2022, 17:37
Estimated value (without VAT)
1 132 406,35 MDL
Achizitii.md ID
21053967
MTender ID
Type of procedure
Open tender
Award criteria
The lowest price
Delivery address
MD-2009, MOLDOVA, mun.Chişinău, mun.Chişinău, MD-2009, Republica Moldova, Chişinău str. Cosmescu 3
Contract period
1 May 2022 03:00 - 31 Dec 2022 02:00
List of positions
1)
Title
Lot nr. 1 Bandaj (Fase) de tifon, 5m x 10cm, nesterila, densitatea min 32g/m2
CPV: 33100000-1 - Medical equipments
Quantity: 387744.0
Unit of measurement: Bucata
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Documents of the procurement procedure
anunt de participare din 04.04.2022.pdf
anunt de participare din 04.04.2022.pdf
Documents history
-
anunt de participare din 04.04.2022.pdf
anunt de participare din 04.04.2022.pdf
ID: 23c1ab31-d534-4c2b-97af-f6e79562f1dd
Bidding Documents
-
anunt de participare.pdf
anunt de participare.pdf
ID: 23c1ab31-d534-4c2b-97af-f6e79562f1dd
Bidding Documents
-
anunt de participare.pdf
anunt de participare.pdf
ID: 23c1ab31-d534-4c2b-97af-f6e79562f1dd
Bidding Documents
Bidding Documents
-
4.04.22 17:37
caiet de sarcini din 04.04.2022.pdf
caiet de sarcini din 04.04.2022.pdf
Documents history
-
caiet de sarcini din 04.04.2022.pdf
caiet de sarcini din 04.04.2022.pdf
ID: 26f33ce9-8b3b-4dfa-88c7-5977f69bbc36
Bidding Documents
-
caiet de sarcini.pdf
caiet de sarcini.pdf
ID: 26f33ce9-8b3b-4dfa-88c7-5977f69bbc36
Bidding Documents
-
caiet de sarcini.pdf
caiet de sarcini.pdf
ID: 26f33ce9-8b3b-4dfa-88c7-5977f69bbc36
Bidding Documents
Bidding Documents
-
4.04.22 17:37
caiet de sarcini pentru publicare.docx
Documents history
-
caiet de sarcini pentru publicare.docx
ID: ac817697-7b8b-494e-b221-0eaad6b8d06e
Bidding Documents
-
caiet de sarcini.docx
ID: ac817697-7b8b-494e-b221-0eaad6b8d06e
Bidding Documents
-
caiet de sarcini pentru publicare.docx
ID: ac817697-7b8b-494e-b221-0eaad6b8d06e
Bidding Documents
Bidding Documents
-
4.04.22 17:37
model-contract.doc
Documents history
-
model-contract.doc
ID: fed1fcf8-f35c-42ed-8a49-c6182a6b4bfe
Bidding Documents
-
contract model dispozitive.doc
ID: fed1fcf8-f35c-42ed-8a49-c6182a6b4bfe
Bidding Documents
-
model-contract.doc
ID: fed1fcf8-f35c-42ed-8a49-c6182a6b4bfe
Bidding Documents
Bidding Documents
-
4.04.22 17:37
The offers of the participants are available below, you can view the documents for the offers by clicking on the folder icon.
Based on the Working Group Decision, the selection of a winner requires:
1) Choose winner by clicking the button.
2) Отправить в течении 3 дней на почту AAP bap@tender.gov.md отсканированное решение рабочей группы.
4) After choosing the winner, press the button: "Confirm"..
Qualification
№
Participant(s) name(s)
Normalized price
Status
1
Participant(s) name(s):
Tetis International Co. SRL
Normalized price:
951 911,52 MDL
Status:
Winner
corespunde tuturor cerintelor
20.04.22 18:53
Reason: corespunde tuturor cerintelor
Qualification documents
Documents folder missing
Documents provided with the proposal
anexa 7;anexa 8;anexa 22;anexa 23.signed.pdf
anexa 7;anexa 8;anexa 22;anexa 23.signed.pdf
ID: 01aa1820-7b17-49df-9ba0-69f232f34351
Qualification documents
Date of download:
14.04.22 12:37
Opening date:
15.04.22 13:40
Qualification documents
Date of download:
14.04.22 12:37
Opening date:
15.04.22 13:40
Qualification documents
Date of download:
14.04.22 12:37
Opening date:
15.04.22 13:40
Qualification documents
Date of download:
14.04.22 12:37
Opening date:
15.04.22 13:40
Qualification documents
Date of download:
14.04.22 12:36
Opening date:
15.04.22 13:40
cert de atribuire contului bancar.signed.pdf
cert de atribuire contului bancar.signed.pdf
ID: 4ba73e41-1f38-447b-87d9-bf7dfc808db9
Qualification documents
Date of download:
14.04.22 12:37
Opening date:
15.04.22 13:40
Qualification documents
Date of download:
14.04.22 12:37
Opening date:
15.04.22 13:40
Qualification documents
Date of download:
14.04.22 12:37
Opening date:
15.04.22 13:40
Qualification documents
Date of download:
14.04.22 12:37
Opening date:
15.04.22 13:40
certificat de inregistrare.signed.pdf
certificat de inregistrare.signed.pdf
ID: ed62d3d4-bcc4-41eb-83d4-b9b172daa756
Qualification documents
Date of download:
14.04.22 12:37
Opening date:
15.04.22 13:40
Qualification documents
Date of download:
14.04.22 12:36
Opening date:
15.04.22 13:40
2
Participant(s) name(s):
Pharmony
Normalized price:
1 077 928,32 MDL
Status:
Cancelled
Other grounds for rejecting the offer
15.04.22 13:58
Reason: Other grounds for rejecting the offer
Qualification documents
Documents folder missing
Documents provided with the proposal
Eligibility documents
Date of download:
14.04.22 14:54
Opening date:
14.04.22 17:37
gauze bandage 10cmx5m- non sterile- tds.semnat.pdf
gauze bandage 10cmx5m- non sterile- tds.semnat.pdf
ID: 11a3627f-2563-4ee8-9db7-025cd7fcf960
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
cerere de particip.semnat (28).pdf
cerere de particip.semnat (28).pdf
ID: 140466ad-6747-475d-9281-9f4212215694
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
confirmletter-mdr--v-medical.semnat.pdf
confirmletter-mdr--v-medical.semnat.pdf
ID: 3373d3ce-5a16-457c-982b-31a078f353fa
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
specificatia de pret_avs (1).semnat.pdf
specificatia de pret_avs (1).semnat.pdf
ID: 69882016-166f-46be-a95d-bf9767423d61
Financial proposal
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
certificat de atribuire a contului bancar.semnat (14).pdf
certificat de atribuire a contului bancar.semnat (14).pdf
ID: 74d68208-b3a7-4a67-92ae-7eeed31fd68b
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
gauze bandage 10cmx5m- non sterile - testing report.semnat.pdf
gauze bandage 10cmx5m- non sterile - testing report.semnat.pdf
ID: 86863024-4a1e-4bff-b093-3d3675ac7e82
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
declaratie _valab_oferta.semnat (28).pdf
declaratie _valab_oferta.semnat (28).pdf
ID: 9445146c-36dd-4dca-b10c-896b71fa0a1d
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
（2020年新证iso) sx 60146805 0001.semnat.pdf
（2020年新证iso) sx 60146805 0001.semnat.pdf
ID: 99224fd4-e274-4058-873a-1de6957d63b7
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
comun06214220220412105153.semnat.pdf
comun06214220220412105153.semnat.pdf
ID: a2fa7beb-83c4-494e-b118-401ecebf711c
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
duae_ro_0 (1) (21).semnat.pdf
duae_ro_0 (1) (21).semnat.pdf
ID: b574f676-8560-4be2-9b49-5a043c999c5d
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
pharmony_12042022095256.semnat.pdf
pharmony_12042022095256.semnat.pdf
ID: b8c7441b-45cd-428b-8a43-d6b4cf473aac
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
specificatia tehnica.semnat.pdf
specificatia tehnica.semnat.pdf
ID: bba46470-4626-4607-8c8a-8788fc42318d
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
declaratie inregistrare dispozitive.semnat (5).pdf
declaratie inregistrare dispozitive.semnat (5).pdf
ID: c0b20097-569f-4522-a32b-32bed902e155
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
situatii financiare 2020 (2).semnat (19).pdf
situatii financiare 2020 (2).semnat (19).pdf
ID: c3a1b19f-4346-44a9-9046-edd4aeebdae9
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
extras 2021.24.09.semnat (30).pdf
extras 2021.24.09.semnat (30).pdf
ID: d67eee89-9f99-4405-b6f9-23d624b40a04
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
general doc for class i.semnat.pdf
general doc for class i.semnat.pdf
ID: eab5c387-0045-45ec-9b7e-a288e9e8bf48
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
Qualification documents
Date of download:
14.04.22 14:35
Opening date:
15.04.22 13:58
3
Participant(s) name(s):
DITA ESTFARM S.R.L
Normalized price:
1 306 658,51 MDL
Status:
Cancelled
Other grounds for rejecting the offer
15.04.22 15:26
Reason: Other grounds for rejecting the offer
Qualification documents
Documents folder missing
Documents provided with the proposal
duaesemnat.pdf
ID: 06abd1de-6a7c-4e3c-b851-01b1c5e05f37
Eligibility documents
Date of download:
14.04.22 17:02
Opening date:
14.04.22 17:37
iso14079gazlibezsemnat.pdf
ID: 2e53b104-3620-45f2-ab1a-58becc612305
x_technicalDocuments
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
12garantiedeoferta_ld2210200266signedsemnat.pdf
ID: 5e368f5a-155d-4882-82e2-604040cd38b1
Financial proposal
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
agaoglutibbiiso134852016semnat.pdf
ID: 7486b2e4-39e5-41fa-addc-fe07cc48f445
Financial proposal
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
hidrofil_sargi_bezi-1semnat.pdf
ID: 7628aa4b-bbcb-483f-9f46-96a853b4a5f5
x_technicalDocuments
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
documentegeneraleditasemnat.pdf
ID: 77885b45-d8c9-4bb2-9806-e5136f1f1c98
Financial proposal
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
cereredeparticiparesemnat.pdf
ID: ad63b077-aa1d-42c1-b240-f6c5e00a42ad
Financial proposal
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
declaratieprivindvalabilitateaoferteisemnat.pdf
ID: ba1b6b1f-062d-4a11-9170-b6677004c730
Financial proposal
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
anexa23semnat.pdf
ID: bf1d1fe1-5be0-40b3-b1cc-42f2178fdd4a
Financial proposal
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
declaratietermenisemnat.pdf
ID: da632c09-6ad1-4c2e-9508-71a3fb92bf85
Financial proposal
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
agaogllutibbiecbelgesİsemnat.pdf
ID: e03a196b-27d8-4912-875d-733dc86db86c
x_technicalDocuments
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
20042022semnat(1).pdf
ID: e34a9d26-c189-465f-97f3-2db6e086b6d3
Financial proposal
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
anexa22semnat.pdf
ID: fb869e70-1d20-4cb5-93c7-21bf2788d07d
Financial proposal
Date of download:
14.04.22 17:02
Opening date:
15.04.22 15:26
4
Participant(s) name(s):
ICS "Farmina" SRL
Normalized price:
1 319 880,58 MDL
Status:
Cancelled
Other grounds for rejecting the offer
15.04.22 15:30
Reason: Other grounds for rejecting the offer
Qualification documents
Documents folder missing
Documents provided with the proposal
declaration of conformity-vata,tifon,.semnat.pdf
declaration of conformity-vata,tifon,.semnat.pdf
ID: 118e60fa-58b6-4914-8cc0-11bf53e88f41
Qualification documents
Date of download:
14.04.22 13:52
Opening date:
15.04.22 15:30
prezentarea mostrelor declratie.signed.pdf
prezentarea mostrelor declratie.signed.pdf
ID: 191f571e-7142-43da-af09-2f31c0d74093
Qualification documents
Date of download:
14.04.22 13:41
Opening date:
15.04.22 15:30
gauze bandages declaration.signed.pdf
gauze bandages declaration.signed.pdf
ID: 224e7da5-951d-4a4d-bf98-81af748d0be2
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
bandage non-sterile 10cm.signed.pdf
bandage non-sterile 10cm.signed.pdf
ID: 2fc0c0b8-1f04-4c56-bae6-6410d61674c9
Qualification documents
Date of download:
14.04.22 13:52
Opening date:
15.04.22 15:30
ce declaration of conformity (1).semnat.pdf
ce declaration of conformity (1).semnat.pdf
ID: 40787080-877b-48bf-806a-422151acb6e0
Qualification documents
Date of download:
14.04.22 13:52
Opening date:
15.04.22 15:30
certificat de inregistrare.signed.pdf
certificat de inregistrare.signed.pdf
ID: 43271af1-d6ca-4bcf-815c-5f501790b166
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
declaratie privind valabilitatea ofertei.signed.pdf
declaratie privind valabilitatea ofertei.signed.pdf
ID: 445c6e21-a5cc-43e0-98bf-44cbb1863d8d
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
garantia pentru oferta capcs.signed.pdf
garantia pentru oferta capcs.signed.pdf
ID: 55bf4330-7dea-4ddf-8aa2-332be8086c7b
Financial proposal
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
баланс фармина 2020.signed.pdf
баланс фармина 2020.signed.pdf
ID: 58149431-4759-4f1c-b45e-a7463cf5419a
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
specificatii tehnice.signed.pdf
specificatii tehnice.signed.pdf
ID: 7d6903c7-ff1c-4093-9927-b66e4725637e
Financial proposal
Date of download:
14.04.22 13:41
Opening date:
15.04.22 15:30
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
inregistrarea amdm.signed.pdf
inregistrarea amdm.signed.pdf
ID: 870cee43-3178-430c-9944-7cd1036cb8ce
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
termenul de valabilitate.signed.pdf
termenul de valabilitate.signed.pdf
ID: 9562ce7e-dc49-459d-a1f5-0cf5cbee739d
Qualification documents
Date of download:
14.04.22 13:41
Opening date:
15.04.22 15:30
cerere de participare.signed.pdf
cerere de participare.signed.pdf
ID: 96b5180f-42dd-4828-a189-bb2e92d897dc
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
rechizite bancare mobias.signed.pdf
rechizite bancare mobias.signed.pdf
ID: b2d89684-fe5c-49ac-951c-fa456e82cca5
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
specificatii de pret.signed.pdf
specificatii de pret.signed.pdf
ID: cc39942f-c6d9-4992-a2f0-2c315bd48a1b
Financial proposal
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
lista fondatorilor.signed.pdf
lista fondatorilor.signed.pdf
ID: d358ffbf-675a-4b3f-999c-9a93f1a7bf4f
Qualification documents
Date of download:
14.04.22 13:46
Opening date:
15.04.22 15:30
lipsa restantelor 19.04.signed.pdf
lipsa restantelor 19.04.signed.pdf
ID: eec60748-d07e-434d-bc9b-ae4837f5ce03
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
extras farmina martie 2022-1.signed.pdf
extras farmina martie 2022-1.signed.pdf
ID: f4292958-e1af-4a43-9889-816a8b658efc
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
Qualification documents
Date of download:
14.04.22 13:42
Opening date:
15.04.22 15:30
5
Participant(s) name(s):
SC"Imunotehnomed"SRL
Normalized price:
1 360 981,44 MDL
Status:
Cancelled
Other grounds for rejecting the offer
15.04.22 15:36
Reason: Other grounds for rejecting the offer
Qualification documents
Documents folder missing
Documents provided with the proposal
06_certificat cont. curente imt.signed.pdf
06_certificat cont. curente imt.signed.pdf
ID: 03fd3671-c5f5-4b60-af1c-430b02ae6b3a
Qualification documents
Date of download:
14.04.22 16:45
Opening date:
15.04.22 15:31
04. duae_ro_completat_itm 21053967.signed.pdf
04. duae_ro_completat_itm 21053967.signed.pdf
ID: 2167da1d-ebfa-4d3c-9ffc-de4c9d624405
Qualification documents
Date of download:
14.04.22 16:45
Opening date:
15.04.22 15:31
10_raport financiar 2020_itm.signed.pdf
10_raport financiar 2020_itm.signed.pdf
ID: 2455d677-5d2b-4a27-910b-775755cf40f0
Qualification documents
Date of download:
14.04.22 16:45
Opening date:
15.04.22 15:31
03. an. nr. 22 - specificații de preț 21053967.signed.pdf
03. an. nr. 22 - specificații de preț 21053967.signed.pdf
ID: 330a2452-8cb7-4e4a-9f4b-5290b39f0510
Financial proposal
Date of download:
14.04.22 16:45
Opening date:
15.04.22 15:31
Qualification documents
Date of download:
14.04.22 16:46
Opening date:
15.04.22 15:31
02. an. nr. 22 - specificaţii tehnice 21053967.signed.pdf
02. an. nr. 22 - specificaţii tehnice 21053967.signed.pdf
ID: 6126afd3-49f5-4a6e-81f9-eb56aaa151f6
Financial proposal
Date of download:
14.04.22 16:45
Opening date:
15.04.22 15:31
model gb licitatie achizitii publice lucrari f com tf 62 01.semnat (5).signed.pdf
model gb licitatie achizitii publice lucrari f com tf 62 01.semnat (5).signed.pdf
ID: 7143de97-34be-427e-af65-832d47dc60fe
Qualification documents
Date of download:
14.04.22 16:45
Opening date:
15.04.22 15:31
iso 14079 gazli bez.signed.pdf
iso 14079 gazli bez.signed.pdf
ID: 71e5557f-b98b-4e47-9a5f-bd59ad4faf84
Qualification documents
Date of download:
14.04.22 16:46
Opening date:
15.04.22 15:31
07. lista fondatorilor.signed.pdf
07. lista fondatorilor.signed.pdf
ID: 902d0571-f749-41c2-afba-98d4c92bdcb1
Qualification documents
Date of download:
14.04.22 16:45
Opening date:
15.04.22 15:31
Qualification documents
Date of download:
14.04.22 16:46
Opening date:
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12.13.14 declaratie 21053967.signed.pdf
12.13.14 declaratie 21053967.signed.pdf
ID: af80f75c-8cc5-4b84-adc7-150b8bdf26fa
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ordin 15-a (semn. electronica).semnat.signed.pdf
ordin 15-a (semn. electronica).semnat.signed.pdf
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hidrofil sargi bezi alban.signed.pdf
hidrofil sargi bezi alban.signed.pdf
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uygunluk beyani non steri̇l.signed.pdf
uygunluk beyani non steri̇l.signed.pdf
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08_extras_rs_ imt_17 01 22.signed.pdf
08_extras_rs_ imt_17 01 22.signed.pdf
ID: cd8468e3-4407-4c68-ae93-30f8e24116a0
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tf02-kullanim kilavuzu non steri̇l.signed.pdf
tf02-kullanim kilavuzu non steri̇l.signed.pdf
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08_certificat de inregistrare_itm.signed.pdf
08_certificat de inregistrare_itm.signed.pdf
ID: dbb77ba1-86b6-4aa1-97d4-c9dc4df51103
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09_certif. lipsa datorii fisc 12.04.22.signed.pdf
09_certif. lipsa datorii fisc 12.04.22.signed.pdf
ID: f035fba8-032c-4a14-91c5-d1c8ac446369
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The history of the auction
View auction
Lot nr. 1 Bandaj (Fase) de tifon, 5m x 10cm, nesterila, densitatea min 32g/m2
Date:
6 Apr 2022, 13:57
Question's name:
Produse fără marcaj CE
Question:
Bună Ziua,
Pentru produsele fără marcaj CE, este necesar ISO 13485 sau ISO 9001?
Answer (6 Apr 2022, 15:29):
Conform caietului se sarcini este menționat în felul următor: Pentru bunurile fără marcaj CE să fie ambalate și etichetate, cu indicarea denumirii și adresei producătorului, denumirea și codul produsului, numărului lotului, data fabricării lotului, data expirării lotului, țara de origine. Pe ambalajul produsului să fie indicate Pictogramele adecvate de performanţă şi trimiterea la standarde EN, GOST, altele .
Mostre - Se vor prezenta 2 buc la solicitarea autorității contractante, ambalate şi etichetate (se acceptă inscripția pe ambalaj în una din limbile de circulație internațională) cu specificare obligatorie a modelului articolului, producătorului și țării de origine pe ambalajul original al mostrei.
*Pentru dispozitivele medicale Înregistrate în Registrul de Stat al Dispozitivelor Medicale a Agenţiei Medicamentului şi Dispozitivelor Medicale să se prezinte - extras din Registrul de Stat al Dispozitivelor Medicale avizat cu ştampila umedă. *Pentru dispozitivele medicale neînregistrate în Registrul de Stat se vor prezenta următoarele documente: a)Certificat CE sau Declarație de conformitate în funcție de evaluarea conformității cu anexele corespunzătoare pentru produsul dat. b) Certificat ISO 13485 și/sau ISO 9001 (în dependență de categoria produsului).
Astfel, marcajul CE și ISO 13485 sau ISO 9001 sunt două standarde diferite și nu pot fi echivalate.
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