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Polyspike
EUDAMEDClass I (EU MDR)
Ref 13494Model Vial Access Spike Ref 13565Ref 13491Model Vial Access SpikeRef 13493Ref 13559Ref 13495Ref 13490Ref 13068Ref 13496Ref 13561Ref 13567Ref 13550Ref 13560
Identity
- Trade Name
- Polyspike EUDAMEDPolyspike V Plus EUDAMEDVial Access Spike EUDAMED
- Device Name
- Vial Access Spike EUDAMED
- Model / Reference
- Vial Access Spike EUDAMED13494 EUDAMED13565 EUDAMED13491 EUDAMED13493 EUDAMED13559 EUDAMED13495 EUDAMED13490 EUDAMED13068 EUDAMED13496 EUDAMED13561 EUDAMED13567 EUDAMED13550 EUDAMED13560 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095134948 EUDAMED08902095135655 EUDAMED08902095134917 EUDAMED08902095134931 EUDAMED08902095135594 EUDAMED08902095134955 EUDAMED08902095134900 EUDAMED08902095130681 EUDAMED08902095134962 EUDAMED08902095135617 EUDAMED08902095135679 EUDAMED08902095135501 EUDAMED08902095135600 EUDAMED
- Basic UDI-DI
- 890209513068EM EUDAMED890209513490F2 EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDFrance EUDAMEDGreece EUDAMEDItaly EUDAMEDRomania EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Polyspike by Poly Medicure Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890209513068EM | Class I | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000003380
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (13)
- EUDAMED 7b082cb0-5377-498c-b99e-c06a35d7d0cf 61 fields · synced Sep 17, 2026
- EUDAMED bcd4b04c-97d9-4b9c-9eaa-8180edd4116b 61 fields · synced May 18, 2026
- EUDAMED cc76c0f3-253d-44ca-ac9f-be8ec9744ffc 61 fields · synced Jun 14, 2026
- EUDAMED 49c63e6c-8c39-4d5f-9205-040b3ab7e9be 61 fields · synced Jun 18, 2026
- EUDAMED 703e6a25-f9bb-4ff1-9993-2fb730e7ce5d 61 fields · synced Jul 10, 2026
- EUDAMED a3d5d4ad-8a78-4e42-8b3c-8f0f844973be 61 fields · synced Jul 14, 2026
- EUDAMED 58abb3ea-d01c-4ac2-a032-4df48099d38c 61 fields · synced Jul 15, 2026
- EUDAMED 9aac58d4-ee6f-4ca4-88e0-a62ca8089c25 61 fields · synced Jul 18, 2026
- EUDAMED 79b2eb9e-0c2f-4269-bfd4-4fa71ea0b5b0 61 fields · synced Jul 18, 2026
- EUDAMED 7beea999-5350-4f13-b58f-726c7f4df50a 61 fields · synced Jul 24, 2026
- EUDAMED 44baf73c-863b-4ddd-917d-5a96d3f772e8 61 fields · synced Jul 26, 2026
- EUDAMED 5342cd72-d057-4801-82f8-4ca52f51c35d 61 fields · synced Jul 28, 2026
- EUDAMED 5c462f43-63b1-46ec-826f-182e9c8c5c76 61 fields · synced Sep 17, 2026