Headlight with Binocular Loupes
by Zumax Medical CO., LTD. EUDAMED
Active
Ref 859010-10137-000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69450955headlightloupes6E | Date10 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Headlight with Binocular Loupe
- Model / Reference
- 859010-10137-000
- Primary DI / UDI-DI
- 06945095556695
- Basic UDI-DI
- 69450955headlightloupes6E
- EMDN Code
- Q0299,Z12010702
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011126
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Zumax Medical 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