Thumb Orthosis
by OPPO Medical Inc. United States EUDAMED
Ref 3088-BG-L
EMDN Y060699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08402706CL1034P | Date12 Sep 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Upper Extremity Orthoses
- Model / Reference
- 3088-BG-L
- Primary DI / UDI-DI
- 00840270607482
- Basic UDI-DI
- 08402706CL1034P
- EMDN Code
- Y060699 Orthoses, upper extremity - 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 (13)
- Sterile: No
- 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 82b94a80-9c46-420a-b94c-dadd769480a7