Identity
- Trade Name
- UROMED CYSTOBAG TK 4000 EUDAMED
- Device Name
- UB02 EUDAMED
- Model / Reference
- 4810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098816212 EUDAMED
- Basic UDI-DI
- 04250098810021EA EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Uromed Cystobag Tk 4000 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 | 04250098810021EA | Class I | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED 4abf31b2-0de1-49d9-99c9-0e1d204fdf00 61 fields · synced Jul 8, 2026