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Rps Tlso
EUDAMEDClass I (EU MDR)
Ref 241101(2XL/UNI/Black/PB)Ref 241101(L/UNI/Black)Ref 241101(XL/UNI/Black)Ref 241101(2XL/UNI/Black)Ref 241101(L/UNI/Black/PB)
Identity
- Trade Name
- RPS TLSO EUDAMED
- Device Name
- Back Brace (Thoracolumbar Support) EUDAMED
- Model / Reference
- 241101(2XL/UNI/Black/PB) EUDAMED241101(L/UNI/Black) EUDAMED241101(XL/UNI/Black) EUDAMED241101(2XL/UNI/Black) EUDAMED241101(L/UNI/Black/PB) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964468141 EUDAMED04719964466345 EUDAMED04719964466338 EUDAMED04719964466321 EUDAMED04719964468127 EUDAMED
- Basic UDI-DI
- 47199644624WC EUDAMED
- EMDN Code
- Y060309 THORACOLUMBOSACRAL 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 Tlso 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 | 47199644624WC | 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 (5)
- EUDAMED 69d84dd7-04eb-46d0-8be9-dbc022d92a52 61 fields · synced Oct 6, 2026
- EUDAMED 5004ea72-53bf-4fef-85ba-62fa018d0683 61 fields · synced May 17, 2026
- EUDAMED bb76c78f-9a8c-4da2-8050-f4d5ec7165b6 61 fields · synced May 17, 2026
- EUDAMED 1b119f53-df37-464c-b964-936a2750a5d4 61 fields · synced May 19, 2026
- EUDAMED e985f89b-0b94-44c9-95be-4da6af283a57 61 fields · synced May 19, 2026