SIMPLE Wrist brace W2
by Simple Medical (Shenzhen) Limited 4 variants
Ref 42004-LModel 31003,31004,31020,31302,30303,31501,31502,31801,31804,31805,31806,31807,31808,31809,31901,31906,30903,30904,41003,41004,41011,41012,41301,31001,31002,31010,31011,31012,31013,31014,31015,31017,31018,31019,31020,41009,42001,42003,42004,52301
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 | Number697124454UpperExtremityXM 06971244540628 | Date19 May 2026 | 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- Withdrawn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
- Model / Reference
- 31003, 31004, 31020, 31302, 30303, 31501, 31502, 31801, 31804, 31805, 31806, 31807, 31808, 31809, 31901, 31906, 30903, 30904, 41003, 41004, 41011, 41012, 41301, 31001, 31002, 31010, 31011, 31012, 31013, 31014, 31015, 31017, 31018, 31019, 41009, 42001, 42003, 42004, 52301, 42004-L
- Primary DI / UDI-DI
- 06971244540628
- Basic UDI-DI
- 697124454UpperExtremityXM
- Direct Marketing DI
- 06971244540628
- EMDN Code
- Y060612 Wrist-hand orthoses
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000013198
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Simple Medical (Shenzhen) Limited
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