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Lumbofit Support
EUDAMEDClass I (EU MDR)
Ref 231302(L/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 231302(XL/UNI/Black)Ref 231302(S/UNI/Black)
Identity
- Trade Name
- Lumbofit 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 EUDAMED231302(L/UNI/Black) EUDAMED231302(XL/UNI/Black) EUDAMED231302(S/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872867302 EUDAMED04719872867319 EUDAMED04719872867289 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
Lumbofit 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 (3)
- EUDAMED 3506321e-5143-4707-b48a-adae145cfc3f 61 fields · synced Oct 6, 2026
- EUDAMED 21bca8a7-869f-4ad8-a4f3-70c1b49629e8 61 fields · synced May 17, 2026
- EUDAMED 7f4d1df1-7948-45a2-8ab1-b239734923ab 61 fields · synced May 19, 2026