Hinged Knee Brace
by OPPO Medical Inc. United States EUDAMED
Ref 2137-BG-L
EMDN Y061299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08402706CL1024M | Date12 Sep 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Lower Extremity Orthoses
- Model / Reference
- 2137-BG-L
- Primary DI / UDI-DI
- 00840270603576
- Basic UDI-DI
- 08402706CL1024M
- EMDN Code
- Y061299 Lower extremity orthoses - other
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- US-MF-000005202
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from OPPO Medical Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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 517a5ddf-fb09-416f-86f9-40eac999af3d