Disposable Urinary Drainage Bag
by Changzhou CareU Medical Instruments Co., Ltd. 155 variants
Ref CU-BT-B-900mlModel CU-JB-2500ml
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697299251DUDBRN 06972992511014 | Date6 Oct 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- CU-JB-2500ml, CU-BT-B-900ml
- Primary DI / UDI-DI
- 06972992511014
- Basic UDI-DI
- 697299251DUDBRN
- EMDN Code
- A060301 Collection bags and other containers for drainages and fistulas, single use
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000027623
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Changzhou CareU Medical Instruments Co., Ltd.
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Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No