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AV Fistula Needle with/without safety features
EUDAMEDClass IIa (EU MDR)
Ref 91121Model AV Fistula Needle with/without safety features
Identity
- Trade Name
- AV Fistula Needle with/without safety features EUDAMED
- Device Name
- AV Fistula Needle EUDAMED
- Model / Reference
- AV Fistula Needle with/without safety features EUDAMED91121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095911211 EUDAMED
- Basic UDI-DI
- 890209590031FZ EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa 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
AV Fistula Needle with/without safety features by Poly Medicure Limited — Class IIa — 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 | 890209590031FZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043011
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED a031b3a2-5ef3-491a-bf48-e074f04e5cae 61 fields · synced Jun 17, 2026