Fibre Diagnostic Otoscope
by Chin Kou Medical Instrument Co., Ltd. 4 variants
Ref CK-939AModel CK-938
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 | Number471989020OSCK93XUE 04719890209412 | Date1 Jul 2026 | 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- Withdrawn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
- Otoscope
- Model / Reference
- CK-938, CK-939A
- Primary DI / UDI-DI
- 04719890209412
- Basic UDI-DI
- 471989020OSCK93XUE
- EMDN Code
- Z12149006 Direct outpatient otoscopes
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- TW-MF-000042725
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Chin Kou Medical Instrument Co., Ltd.
See all devices from Chin Kou Medical Instrument 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