Dr-W008
by A-Mi Global Co., Ltd. South Korea EUDAMED
Ref AMIDR-W008
EMDN Y060612
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880925756389MB | Date28 Nov 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Upper Extremity Orthoses
- Model / Reference
- AMIDR-W008
- Primary DI / UDI-DI
- 08809257567708
- Basic UDI-DI
- 880925756389MB
- EMDN Code
- Y060612 Wrist-hand orthoses
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- KR-MF-000017572
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Ami Global Co., Ltd
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 909614c4-87ad-4194-807a-5a9d5f3994a4