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Rps Lso
EUDAMEDClass I (EU MDR)
Ref 231107(2XL/UNI/Black)Model Abdominal Binder:230001 Elastic Lumbar Support:231201 Lumbar Stabilizer:231206 Lumbar Support:231205 Lumbar Support With Stays:231202 Lumbar Support With Stays:238001 Lumbofit Panel Brace:231303 Lumbofit Support:231302 etcRef 231108(S/UNI/Black)Ref 231107(M/UNI/Black)Ref 231107(L/UNI/Black)Ref 231108(L/UNI/Black)Ref 231108(XL/UNI/Black)
Identity
- Trade Name
- RPS LSO EUDAMEDRPS LSO T9 EUDAMED
- Device Name
- Back Brace (Waist Support) EUDAMED
- Model / Reference
- Abdominal Binder:230001 Elastic Lumbar Support:231201 Lumbar Stabilizer:231206 Lumbar Support:231205 Lumbar Support With Stays:231202 Lumbar Support With Stays:238001 Lumbofit Panel Brace:231303 Lumbofit Support:231302 etc EUDAMED231107(2XL/UNI/Black) EUDAMED231108(S/UNI/Black) EUDAMED231107(M/UNI/Black) EUDAMED231107(L/UNI/Black) EUDAMED231108(L/UNI/Black) EUDAMED231108(XL/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892931885 EUDAMED04719892931939 EUDAMED04719892931854 EUDAMED04719892931861 EUDAMED04719892931915 EUDAMED04719892931908 EUDAMED
- Basic UDI-DI
- 47198728623WC 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 by Zhangpu Ortholife 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 | 47198728623WC | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (6)
- EUDAMED 9eb20941-9c04-4372-a581-e239fda1adc4 61 fields · synced Oct 6, 2026
- EUDAMED a2419653-2a76-4357-9a6b-bd95d5c44a4f 61 fields · synced May 16, 2026
- EUDAMED 12b67cb8-e84c-4bce-9484-6b081a2513e7 61 fields · synced May 17, 2026
- EUDAMED bc413bf9-fff6-4c7e-b7e0-849b87d8f3f8 61 fields · synced May 17, 2026
- EUDAMED c1328466-d0f7-419b-849c-d6e37315a450 61 fields · synced May 19, 2026
- EUDAMED ab2cc6cb-dd82-42f7-a766-dcbf9b579837 61 fields · synced May 19, 2026