Teqler
by Wenzhou Bokang Instruments Co., Ltd 4 variants
Ref T401127Model BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69310386STE0001LZ 06931038631031 | Date6 May 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- stethoscope
- Model / Reference
- BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012, T401127
- Primary DI / UDI-DI
- 06931038631031
- Basic UDI-DI
- 69310386STE0001LZ
- EMDN Code
- C9005 Phonendoscopes and stethoscopes
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000021505
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Wenzhou Bokang Instruments Co., Ltd
Properties
Other properties (13)
- Sterile: No
- 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