Sterile trocars for single use (Optical Bladeless Balloon ring fixation type) Dual pack
by Genmed Enterprises International Ltd 2 variants
Ref GN-TOF0510-D, GN-TOF0575-D, GN-TOF1010-DModel TW/TO/TB/TWF/TOHF/GA Series
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 | Number506091140TROCARA4 | Date21 Jul 2022 | 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- Withdrawn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
- Sterile Trocars for Single Use
- Model / Reference
- TW/TO/TB/TWF/TOHF/GA Series, GN-TOF0510-D, GN-TOF0575-D, GN-TOF1010-D
- Primary DI / UDI-DI
- 05060911400578, 05060911400561, 05060911400554
- Basic UDI-DI
- 506091140TROCARA4
- EMDN Code
- K01010103 Optical trocar, single-use
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- GB-MF-000010687
- Authorised representative
- GENMED ENTERPRISES MEDICAL LIMITED IE-AR-000010419
Other devices from Genmed Enterprises International 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