Identity
- Device Name
- Urine bag EUDAMED
- Model / Reference
- 2000ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975498580034 EUDAMED
- Basic UDI-DI
- 697549858000019Z EUDAMED
- EMDN Code
- W05010203 URINE COLLECTION, CONTAINERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Urine bag by K-Med Co., Ltd — 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 | 697549858000019Z | Class I | Active |
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Manufacturer
- Manufacturer
- K-Med Co., Ltd
- EUDAMED SRN
- CN-MF-000024689
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED c8a4d911-bf24-4e66-bf6e-b786db450ec4 61 fields · synced Oct 5, 2026