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Lumbar Support With Stays
EUDAMEDClass I (EU MDR)
Ref 231202(S/UNI/Gray&Silver)Model Abdominal Binder 230001 Elastic Lumbar Support 231201 Lumbar Stabilizer 231206 Lumbar Support With Stays 231202 Lumbar Support With Stays 238001 Lumbofit Panel Brace 231303 Lumbofit Support 231302 Lumbosacral Support 231204 etcRef 238001(L/UNI/Black)Ref 231202(M/UNI/Gray&Silver)Ref 231202(XL/UNI/Gray&Silver)Ref 231202(2XL/UNI/Gray&Silver)Ref 238001(2XL/UNI/Black)Ref 238001(XL/UNI/Black)
Identity
- Trade Name
- Lumbar Support With Stays EUDAMED
- Device Name
- Back Brace (Waist Support) EUDAMED
- Model / Reference
- Abdominal Binder 230001 Elastic Lumbar Support 231201 Lumbar Stabilizer 231206 Lumbar Support With Stays 231202 Lumbar Support With Stays 238001 Lumbofit Panel Brace 231303 Lumbofit Support 231302 Lumbosacral Support 231204 etc EUDAMED231202(S/UNI/Gray&Silver) EUDAMED238001(L/UNI/Black) EUDAMED231202(M/UNI/Gray&Silver) EUDAMED231202(XL/UNI/Gray&Silver) EUDAMED231202(2XL/UNI/Gray&Silver) EUDAMED238001(2XL/UNI/Black) EUDAMED238001(XL/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892935814 EUDAMED04719892936118 EUDAMED04719892935807 EUDAMED04719892935821 EUDAMED04719892935838 EUDAMED04719892936156 EUDAMED04719892936149 EUDAMED
- Basic UDI-DI
- 47199644623WA EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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 Orthotech 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 | 47199644623WA | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (7)
- EUDAMED 2637b726-3f60-4db4-92e5-e4fa27345e70 61 fields · synced Oct 7, 2026
- EUDAMED acee641e-2a0c-4016-8eec-ec8fba94e8e9 61 fields · synced May 17, 2026
- EUDAMED 9e99b03f-b648-42bf-b8f4-5b4aa6d30184 61 fields · synced May 17, 2026
- EUDAMED 790670de-6181-410d-a06b-a238ed723004 61 fields · synced May 17, 2026
- EUDAMED 8d5293f3-718b-4cb8-96db-c2b4f1aa1b50 61 fields · synced May 17, 2026
- EUDAMED a0bc7ed3-ded5-4f3f-a92c-ef92c18eb692 61 fields · synced May 19, 2026
- EUDAMED eddbf809-dc7a-4e4c-98d9-bb1dbb3ca14a 61 fields · synced May 19, 2026