Rps T9 Pro
by Orthotech Rehabilitation Co., Ltd. EUDAMED
Active
Ref 231109(XL/UNI/Black)Model Abdominal Binder 230001 Elastic Lumbar Support 231201 Lumbar Stabilizer 231206 Lumbar Support With Stays 231202 Lumbar Support With Stays 238001 Lumbofit Panel Brace 231303 Lumbofit Support 231302 Lumbosacral Support 231204 etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number47199644623WA | Date14 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Back Brace (Waist Support)
- Model / Reference
- Abdominal Binder 230001 Elastic Lumbar Support 231201 Lumbar Stabilizer 231206 Lumbar Support With Stays 231202 Lumbar Support With Stays 238001 Lumbofit Panel Brace 231303 Lumbofit Support 231302 Lumbosacral Support 231204 etc, 231109(XL/UNI/Black)
- Primary DI / UDI-DI
- 04719964466307
- Basic UDI-DI
- 47199644623WA
- EMDN Code
- Y060308 Lumbosacral spine orthoses
- Device Class
- Class I
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000051924
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Orthotech Rehabilitation 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