Sinuscopes
by Tonglu Sike Medical Instrument Co., Ltd. 24 variants
Ref BJ1016HDModel BJ1001，BJ1002，BJ1003，BJ1004，BJ1008，BJ1009，BJ1010，BJ1011，BJ1012，BJ1013，BJ1014，BJ1015，BJ1016HD，BJ1017HD，BJ1018HD，BJ1019HD，BJ1032HD，BJ1033HD，BJ1034HD，BJ1035HD，BJ1040HD，BJ1041HD，BJ1042HD，BJ1043HD
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 | Number697058187BJ001DP 06975633110423 | Date16 Dec 2025 | 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- Withdrawn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
- Device Name
- Sinuscopes
- Model / Reference
- BJ1001，BJ1002，BJ1003，BJ1004，BJ1008，BJ1009，BJ1010，BJ1011，BJ1012，BJ1013，BJ1014，BJ1015，BJ1016HD，BJ1017HD，BJ1018HD，BJ1019HD，BJ1032HD，BJ1033HD，BJ1034HD，BJ1035HD，BJ1040HD，BJ1041HD，BJ1042HD，BJ1043HD, BJ1016HD
- Primary DI / UDI-DI
- 06975633110423
- Basic UDI-DI
- 697058187BJ001DP
- EMDN Code
- Z12021008 Rhinoscopes
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000051027
- Authorised representative
- endodoctor GmbH DE-AR-000050606
Other devices from Tonglu Sike Medical Instrument Co., Ltd.
See all devices from Tonglu Sike Medical Instrument Co., Ltd. →
Properties
Other properties (12)
- Sterile: No
- Implantable: 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