BM 100% Silicone Foley Catheters
by Bonree Medical Co., Ltd. China EUDAMED
Ref 330 08 00 2Model 2 Way: 6FR, 8FR, 10FR, 12FR, 14FR, 16FR, 18FR, 20FR, 22FR, 24FR, 26FR 3 Way: 16FR, 18FR, 20FR, 22FR, 24FR, 26FR EMDN U010299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697209192SFC21JA | Date10 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- 100% Silicone Foley Catheters
- Model / Reference
- 2 Way: 6FR, 8FR, 10FR, 12FR, 14FR, 16FR, 18FR, 20FR, 22FR, 24FR, 26FR 3 Way: 16FR, 26FR, 330 08 00 2
- Primary DI / UDI-DI
- 06942382611303
- Basic UDI-DI
- 697209192SFC21JA
- Direct Marketing DI
- 06942382611303
- EMDN Code
- U010299 Urethral prostatic and bladder catheters, with balloon - other
- Device Class
- Class IIb
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000017844
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Bonree Medical Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 06942382611303|697209192SFC21JA