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Elastic Lumbar Support
EUDAMEDClass I (EU MDR)
Ref 231201(M/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 231201(2XL/UNI/Gray&Silver)Ref 231201(S/UNI/Gray&Silver)Ref 231201(L/UNI/Gray&Silver)
Identity
- Trade Name
- Elastic Lumbar 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 EUDAMED231201(M/UNI/Gray&Silver) EUDAMED231201(2XL/UNI/Gray&Silver) EUDAMED231201(S/UNI/Gray&Silver) EUDAMED231201(L/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872860990 EUDAMED04719872861027 EUDAMED04719872861003 EUDAMED04719872860983 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
Elastic Lumbar 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 (4)
- EUDAMED d987e01d-80f4-4658-895c-b7615b784462 61 fields · synced Oct 6, 2026
- EUDAMED 08b1a4fc-5cd5-4175-b173-8f2b7c805058 61 fields · synced May 17, 2026
- EUDAMED 509311fe-c996-4d66-8922-2eccb512fb04 61 fields · synced May 17, 2026
- EUDAMED fab790e6-e57f-4476-9ffa-3300691d3134 61 fields · synced May 18, 2026