Light Guide Cable
by Guangdong Optomedic Technologies, Inc. 2 variants
Ref FIB-H3545Model FIB-H3045, FIB-H3545, FIB-H3035
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 | Number697303129WS0701EV 06973031299788 | Date26 Sep 2024 | 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- Withdrawn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
- Model / Reference
- FIB-H3045, FIB-H3545, FIB-H3035
- Primary DI / UDI-DI
- 06973031299788
- Basic UDI-DI
- 697303129WS0701EV
- Direct Marketing DI
- 06973031299788
- EMDN Code
- Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000011588
- Authorised representative
- Share info GmbH DE-AR-000005132
Other devices from Guangdong Optomedic Technologies, Inc.
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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