Identity
- Trade Name
- UROMED CYSTOBAG Urimeter 400 EUDAMED
- Device Name
- UMS01 EUDAMED
- Model / Reference
- 4830 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098816304 EUDAMED
- Basic UDI-DI
- 04250098810026EL EUDAMED
- EMDN Code
- V030206 UROLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UROMED CYSTOBAG Urimeter 400 by UROMED Kurt Drews KG — Class I — 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 | 04250098810026EL | Class I | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED 79643d61-6e93-41e0-8e64-a84a8a2fffd4 61 fields · synced Oct 6, 2026