Identity
- Trade Name
- Disposable urinary drainage bag EUDAMED
- Device Name
- Disposable urinary drainage bag EUDAMED
- Model / Reference
- CU-FPA-TT-2000ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972992510451 EUDAMED
- Basic UDI-DI
- 697299251NOSTVF 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
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 | 697299251NOSTVF | 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 e57ce574-0081-418d-9df5-4864d46608d7 61 fields · synced Jun 19, 2026