Bm
by Zhejiang Baite Medical Appliances Co., Ltd. 64 variants
Ref BM0610Model FR12
Active
CE MDD
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/MDD | NumberB-06974269381511 06974269381511 | Date17 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- tiemann catheter
- Model / Reference
- FR12, BM0610
- Primary DI / UDI-DI
- 06974269381511
- Basic UDI-DI
- B-06974269381511
- EMDN Code
- U01010502 Nelaton catheters, non self-lubricating
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000021983
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Zhejiang Baite Medical Appliances Co., Ltd.
See all devices from Zhejiang Baite Medical Appliances Co., Ltd. →
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No