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Rps Knit Lso
EUDAMEDClass I (EU MDR)
Ref 231110(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 231110(M/UNI/Black)Ref 231110(S/UNI/Black)
Identity
- Trade Name
- RPS KNIT 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 EUDAMED231110(L/UNI/Black) EUDAMED231110(M/UNI/Black) EUDAMED231110(S/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964467564 EUDAMED04719964467557 EUDAMED04719964467540 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 Knit Lso 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 |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED bc95fae9-12e6-4d36-b374-94ca3a137538 61 fields · synced Oct 6, 2026
- EUDAMED 6ce75ba4-8988-459f-99c2-6158a18ca371 61 fields · synced May 17, 2026
- EUDAMED c600623f-6443-415e-88fc-fef92e8b1750 61 fields · synced May 17, 2026