Identity
- Trade Name
- POCHE A URINE, 2L EUDAMED
- Device Name
- Urine Bag EUDAMED
- Model / Reference
- UB001-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615370005097 EUDAMED
- Basic UDI-DI
- 697434391KBNT5 EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Poche A Urine, 2l by Changshu Kangbao Medical Appliance Factory — 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 | 697434391KBNT5 | Class I | Active |
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Manufacturer
- Manufacturer
- Changshu Kangbao Medical Appliance Factory
- EUDAMED SRN
- CN-MF-000024507
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 1d4dbe4e-9a8d-42d8-876b-659a0c7d549a 61 fields · synced Jun 18, 2026