LoopView
by MacroLux Medical Technology Co., Ltd. 2 variants
Ref B27-CGModel B27-C/ B27-CG/ B38-C/ B38-CG/ B50-C/ B50-CG/ B58-C/ B58-CG
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 | Number697533962003MN 06975339622442 | Date29 Oct 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- Withdrawn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
- Single-Use Digital Flexible Bronchoscope
- Model / Reference
- B27-C/ B27-CG/ B38-C/ B38-CG/ B50-C/ B50-CG/ B58-C/ B58-CG, B27-CG
- Primary DI / UDI-DI
- 06975339622442
- Basic UDI-DI
- 697533962003MN
- EMDN Code
- Z12020802 Video bronchoscopes
- Device Class
- Class IIa
- 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