Identity
- Device Name
- Sterile Nelaton Catheter EUDAMED
- Model / Reference
- 131-1250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62851000260426 EUDAMED
- Basic UDI-DI
- 62851131-1250UK EUDAMED
- EMDN Code
- A03010202 UROLOGICAL IRRIGATION CONTROLLERS 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 Nelaton Catheter 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 | 62851131-1250UK | 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 2368bd51-0e85-4e3a-8e92-6243383f28d9 61 fields · synced Aug 1, 2026