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Neoprene Back Support
EUDAMEDClass I (EU MDR)
Ref 231208(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 231208(L/UNI/Gray&Silver)Ref 231208(M/UNI/Gray&Silver)Ref 231208(XL/UNI/Gray&Silver)
Identity
- Trade Name
- Neoprene Back 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 EUDAMED231208(S/UNI/Gray&Silver) EUDAMED231208(L/UNI/Gray&Silver) EUDAMED231208(M/UNI/Gray&Silver) EUDAMED231208(XL/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964463504 EUDAMED04719964463528 EUDAMED04719964463511 EUDAMED04719964463535 EUDAMED
- Basic UDI-DI
- 47199644623WA 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
Neoprene Back 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 (4)
- EUDAMED 4ff53d51-020e-4ad7-ba4a-ac9bd94761cf 61 fields · synced Oct 6, 2026
- EUDAMED ca1b9f92-c8d7-4421-90b4-f5f5fe575110 61 fields · synced May 19, 2026
- EUDAMED 1625e9b9-8fcd-4a27-906d-13514e3507b3 61 fields · synced May 19, 2026
- EUDAMED 82c5cdb0-23b1-459e-892f-abdd24659a1f 61 fields · synced May 19, 2026