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Lumbosacral Support
EUDAMEDClass I (EU MDR)
Ref 231204(S/UNI/Gray&Silver)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 231204(2XL/UNI/Gray&Silver)Ref 231204(L/UNI/Gray&Silver)Ref 231204(M/UNI/Gray&Silver)Ref 231204(3XL/UNI/Gray&Silver)
Identity
- Trade Name
- Lumbosacral Support 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 EUDAMED231204(S/UNI/Gray&Silver) EUDAMED231204(2XL/UNI/Gray&Silver) EUDAMED231204(L/UNI/Gray&Silver) EUDAMED231204(M/UNI/Gray&Silver) EUDAMED231204(3XL/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872861157 EUDAMED04719872861171 EUDAMED04719872861133 EUDAMED04719872861140 EUDAMED04719872868590 EUDAMED
- Basic UDI-DI
- 47198728623WC EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Lumbosacral Support 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 (5)
- EUDAMED 00fec313-f0d7-4e6a-9ab4-b8fb20d37836 61 fields · synced Oct 6, 2026
- EUDAMED 1f158236-f9b4-4838-a687-fb7bbf0431e2 61 fields · synced May 16, 2026
- EUDAMED e8873dd8-97ed-4f25-b544-7afe2be4fb64 61 fields · synced May 17, 2026
- EUDAMED c4e3fdab-a90f-448d-adc9-e916578b5315 61 fields · synced May 18, 2026
- EUDAMED 369f4c11-42b5-49d8-82b0-932a9b5ad048 61 fields · synced May 18, 2026