Identity
- Trade Name
- UROMED Fascial Dilator EUDAMED
- Device Name
- FD01 EUDAMED
- Model / Reference
- 2650.12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098804721 EUDAMED
- Basic UDI-DI
- 04250098810027EN EUDAMED
- EMDN Code
- U03010199 PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
UROMED Fascial Dilator by UROMED Kurt Drews KG — 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 | 04250098810027EN | Class IIa | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED a3e4cfd8-9705-49a0-9c1c-aa27b789cdfe 61 fields · synced Jun 19, 2026