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- Disposable urinary drainage bag
EUDAMEDClass I (EU MDR)
Ref CU-BT-C-750mlModel CU-JB-2500ml
Identity
- Trade Name
- - Disposable urinary drainage bag EUDAMED
- Device Name
- Disposable urinary drainage bag EUDAMED
- Model / Reference
- CU-JB-2500ml EUDAMEDCU-BT-C-750ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972992510734 EUDAMED
- Basic UDI-DI
- 697299251DUDBRN EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
- Disposable urinary drainage bag by Changzhou CareU Medical Instruments 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 | 697299251DUDBRN | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou CareU Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000027623
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED fdca6098-0fee-40a1-b690-0864ca7aabce 61 fields · synced Jun 18, 2026