Back Brace
by Xiamen Twe Orthopedics Co., Ltd EUDAMED
Active
Ref TB001Model TB001,TB002,TB003,TB004,TB005,TB006,TB007,TB008, TB009,TB010,TB011,TB012,TB013,TB014,TB015,TB016 TB017,TB018,TB019,TB020,TB021,TB022,TB023,TB024, TB025,TB026,TB801,TB802,TB803,TB804
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697791740BB5L | Date25 Feb 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Back Brace
- Model / Reference
- TB001, TB002, TB003, TB004, TB005, TB006, TB007, TB008, TB009, TB010, TB011, TB012, TB013, TB014, TB015, TB016 TB017, TB018, TB019, TB020, TB021, TB022, TB023, TB024, TB025, TB026, TB801, TB802, TB803, TB804
- Primary DI / UDI-DI
- 06977917400664
- Basic UDI-DI
- 697791740BB5L
- EMDN Code
- Y090699 Devices for body protection - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045818
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiamen Twe Orthopedics 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