← Back to catalogue
Rps Lso T9
EUDAMEDClass I (EU MDR)
Ref 231108(L/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 etcRef 231108(M/UNI/Black)Ref 231107(S/UNI/Black)Ref 231108(S/UNI/Black)Ref 231107(M/UNI/Black)Ref 231107(L/UNI/Black)
Identity
- Trade Name
- RPS LSO T9 EUDAMEDRPS LSO EUDAMED
- Device Name
- Back Brace (Waist Support) EUDAMED
- 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 EUDAMED231108(L/UNI/Black) EUDAMED231108(M/UNI/Black) EUDAMED231107(S/UNI/Black) EUDAMED231108(S/UNI/Black) EUDAMED231107(M/UNI/Black) EUDAMED231107(L/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964466246 EUDAMED04719964466253 EUDAMED04719964466178 EUDAMED04719964466260 EUDAMED04719964466185 EUDAMED04719964466192 EUDAMED
- Basic UDI-DI
- 47199644623WA EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rps Lso T9 by Orthotech Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 47199644623WA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (6)
- EUDAMED 5e8b774e-c8af-492c-9da0-d3d5dae2cfe3 61 fields · synced Oct 6, 2026
- EUDAMED 0af22f26-16cd-47c9-823d-70fa1734aabf 61 fields · synced May 16, 2026
- EUDAMED 084b4aa5-4a5f-401d-9486-0c0121778290 61 fields · synced May 17, 2026
- EUDAMED 0f32c48d-53b3-4ef6-b5ee-c60aaee98b49 61 fields · synced May 18, 2026
- EUDAMED f14f5167-09dc-42d6-a6a6-70c33fc98b03 61 fields · synced May 19, 2026
- EUDAMED 1b93c94c-4e56-4b51-8dd3-52e5c5852d7a 61 fields · synced May 19, 2026