Identity
- Device Name
- Sterile A.V Fistula Needle EUDAMED
- Model / Reference
- 361-1630 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62851000235844 EUDAMED
- Basic UDI-DI
- 62851361-1630XS 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
Sterile A.V Fistula Needle by Saudi Mais Co. For Medical products — 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 | 62851361-1630XS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Saudi Mais Co. For Medical products
- EUDAMED SRN
- SA-MF-000025189
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED dde2af59-b870-41c9-b0d2-4a41fc902e35 61 fields · synced Jun 19, 2026