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Pulley Back Brace
EUDAMEDClass I (EU MDR)
Ref 231104(L/UNI/Black)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 231104(2XL/UNI/Black)Ref 231104(XL/UNI/Black)Ref 231104(M/UNI/Black)Ref 231104(S/UNI/Black)
Identity
- Trade Name
- Pulley Back Brace 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 EUDAMED231104(L/UNI/Black) EUDAMED231104(2XL/UNI/Black) EUDAMED231104(XL/UNI/Black) EUDAMED231104(M/UNI/Black) EUDAMED231104(S/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964463436 EUDAMED04719964463450 EUDAMED04719964463443 EUDAMED04719964463429 EUDAMED04719964463412 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
Pulley Back Brace 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 51f7fade-d71a-4602-8fa3-58a6a79058ba 61 fields · synced Oct 6, 2026
- EUDAMED 72a5a66d-5d6e-497b-a2e0-fd97cf322040 61 fields · synced May 16, 2026
- EUDAMED 0a1a40bb-8714-4f2e-af8e-5eb16a944561 61 fields · synced May 18, 2026
- EUDAMED b734c4fc-b372-4c6d-a56d-8605d3da74de 61 fields · synced May 19, 2026
- EUDAMED 9f935eee-f233-4d34-8b03-eb67eb219764 61 fields · synced May 19, 2026