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Lumbosacral Support
EUDAMEDClass I (EU MDR)
Ref 231204(3XL/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 231204(XL/UNI/Gray&Silver)Ref 231204(L/UNI/Gray&Silver)Ref 231204(S/UNI/Gray&Silver)Ref 231204(4XL/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 With Stays 231202 Lumbar Support With Stays 238001 Lumbofit Panel Brace 231303 Lumbofit Support 231302 Lumbosacral Support 231204 etc EUDAMED231204(3XL/UNI/Gray&Silver) EUDAMED231204(XL/UNI/Gray&Silver) EUDAMED231204(L/UNI/Gray&Silver) EUDAMED231204(S/UNI/Gray&Silver) EUDAMED231204(4XL/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964463092 EUDAMED04719892935920 EUDAMED04719892935890 EUDAMED04719892935913 EUDAMED04719964463108 EUDAMED
- Basic UDI-DI
- 47199644623WA 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 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 (5)
- EUDAMED 1ce013ed-23c0-493b-a81a-084e6359afce 61 fields · synced Oct 6, 2026
- EUDAMED 1c073ecf-8034-4efe-8787-f7bc6ad6eac2 61 fields · synced May 17, 2026
- EUDAMED 9beb6b08-8c90-41a4-a0b9-88f9ba4cf4b3 61 fields · synced May 18, 2026
- EUDAMED 606655eb-3db3-48fd-8de8-30f2e586c191 61 fields · synced May 18, 2026
- EUDAMED 8f0c3c25-24f5-4693-af63-900e725d9771 61 fields · synced May 19, 2026