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Lumbar Support With Stays
EUDAMEDClass I (EU MDR)
Ref 238001(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 231205(S/UNI/Gray&Silver)Ref 231205(XL/UNI/Gray&Silver)Ref 238001(XL/UNI/Black)Ref 231205(L/UNI/Gray&Silver)Ref 231205(M/UNI/Gray&Silver)Ref 231202(3XL/UNI/Gray&Silver)Ref 231202(2XL/UNI/Gray&Silver)Ref 231202(S/UNI/Gray&Silver)
Identity
- Trade Name
- Lumbar Support With Stays EUDAMEDLumbar 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 EUDAMED238001(2XL/UNI/Black) EUDAMED231205(S/UNI/Gray&Silver) EUDAMED231205(XL/UNI/Gray&Silver) EUDAMED238001(XL/UNI/Black) EUDAMED231205(L/UNI/Gray&Silver) EUDAMED231205(M/UNI/Gray&Silver) EUDAMED231202(3XL/UNI/Gray&Silver) EUDAMED231202(2XL/UNI/Gray&Silver) EUDAMED231202(S/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872861393 EUDAMED04719872861201 EUDAMED04719872861218 EUDAMED04719872861386 EUDAMED04719872861188 EUDAMED04719872861195 EUDAMED04719872869054 EUDAMED04719872861072 EUDAMED04719872861058 EUDAMED
- Basic UDI-DI
- 47198728623WC EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMEDNetherlands 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
Lumbar Support With Stays 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 (9)
- EUDAMED 36b3e1cd-e201-4144-882d-3af7fb417606 61 fields · synced Oct 5, 2026
- EUDAMED 5b473cb2-b397-4d66-931c-a3cd46ed33d9 61 fields · synced May 17, 2026
- EUDAMED 57b089dc-864a-4edf-abdc-2429dd023831 61 fields · synced May 17, 2026
- EUDAMED cae0b414-c4d3-42c1-ac3d-34a57ed56b7d 61 fields · synced May 17, 2026
- EUDAMED 33df7bc4-519a-412f-bb24-deb7b282b3f4 61 fields · synced May 18, 2026
- EUDAMED bd68e213-aa0a-4425-8219-dbc59dfa92c3 61 fields · synced May 18, 2026
- EUDAMED ecb67be1-dd4d-48ce-9765-12d948c593e1 61 fields · synced May 19, 2026
- EUDAMED 399eb208-ef0e-4e37-9d44-ebba6104009a 61 fields · synced May 19, 2026
- EUDAMED 561d9783-249c-4899-98e3-996fbb62d29b 61 fields · synced May 19, 2026