index
by Sterilance Medical (Suzhou) Inc. United States EUDAMED
Ref 10-0124
EMDN V010302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6945630110BA | Date23 Feb 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Surgical Blades
- Model / Reference
- 10-0124
- Primary DI / UDI-DI
- 16945630145251
- Basic UDI-DI
- 6945630110BA
- Unit of Use DI
- 06945630145254
- EMDN Code
- V010302 Blades without safety systems, single-use - not included in other classes
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000002860
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Sterilance Medical (Suzhou) Inc.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 16945630145251|6945630110BA