Clavicle Brace w/2 PE plates
by I-Ming Sanitary Materials Co., Ltd
Ref OH-102
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 | Number4717237TLSO82 | Date6 Nov 2024 | 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- Withdrawn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
- Orthosis, Thoracolumbosacral Spine
- Model / Reference
- OH-102
- Primary DI / UDI-DI
- 04717237020850, 04717237020881, 04717237020867, 04717237020874, 04717237020843
- Basic UDI-DI
- 4717237TLSO82
- Direct Marketing DI
- 0471723702085004717237020881047172370208670471723702087404717237020843
- EMDN Code
- Y060309 Thoracolumbosacral spine orthoses
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- TW-MF-000008612
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from I-Ming Sanitary Materials 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