Identity
- Device Name
- Sterile Foley Catheterization tray EUDAMED
- Model / Reference
- 801-1415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62851000264554 EUDAMED
- Basic UDI-DI
- 62851801-1415XD EUDAMED
- EMDN Code
- U0180 URETHRAL PROSTATIC AND BLADDER CATHETERS - ACCESSORIES 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Foley Catheterization tray 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 | 62851801-1415XD | 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 7dd94582-cfd2-47b0-8834-42de66b22b2e 61 fields · synced Oct 6, 2026