GorgeView
by MacroLux Medical Technology Co., Ltd. 2 variants
Ref R48-CModel R22-C, R30-C, R48-C
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 | Number697533962007MW 06975339625269 | Date13 May 2026 | 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- Withdrawn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
- Single-Use Digital Flexible Rhinolaryngoscope
- Model / Reference
- R22-C, R30-C, R48-C
- Primary DI / UDI-DI
- 06975339625269
- Basic UDI-DI
- 697533962007MW
- EMDN Code
- Z12021006 Video nasopharyngo/laryngoscopes
- Device Class
- Class IIa
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000025085
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from MacroLux Medical Technology Co., Ltd.
See all devices from MacroLux Medical Technology Co., Ltd. →
Properties
Other properties (12)
- 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