Wrist Brace
by Xiamen Ortocare Sports Health Co., Ltd. 24 variants
Ref WR019Model WR001,WR002,WR003,WR004,WR005,WR006,WR007,WR008,WR009,WR010,WR011,WR012,WR015,WR016,WR017,WR018,WR019,WR020,WR021,WR022,WR023,WR024,WR025
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697620010wristbrace001VJ 06976200101875 | Date30 May 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Wrist Brace
- Model / Reference
- WR001, WR002, WR003, WR004, WR005, WR006, WR007, WR008, WR009, WR010, WR011, WR012, WR015, WR016, WR017, WR018, WR019, WR020, WR021, WR022, WR023, WR024, WR025
- Primary DI / UDI-DI
- 06976200101875
- Basic UDI-DI
- 697620010wristbrace001VJ
- EMDN Code
- Y090618 Leg and knee protections (including socks for amputated legs)
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000034229
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Xiamen Ortocare Sports Health Co., Ltd.
See all devices from Xiamen Ortocare Sports Health Co., Ltd. →
Properties
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