Jasper Elbow Supporter
by Ta Lai Sporting Goods Enterprises Co., Ltd. 6 variants
Ref B1003 - XL
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 | Number04715065ELBOWSUPPORTW6 04715065041610 | Date4 Aug 2025 | 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- Withdrawn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
- B1003 - XL
- Primary DI / UDI-DI
- 04715065041610
- Basic UDI-DI
- 04715065ELBOWSUPPORTW6
- EMDN Code
- Y060615 Elbow orthoses
- Device Class
- Class I
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- TW-MF-000029589
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Ta Lai Sporting Goods Enterprises Co., Ltd.
See all devices from Ta Lai Sporting Goods Enterprises Co., Ltd. →
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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