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Jewett Hyperextension Brace
EUDAMEDClass I (EU MDR)
Ref 240006(S/UNI/Gray&Silver)Ref 240002(L/UNI/White)Ref 240002(XL/UNI/White)Ref 240006(L/UNI/Gray&Silver)
Identity
- Trade Name
- Jewett Hyperextension Brace EUDAMED
- Device Name
- Back Brace (Thoracolumbar Support) EUDAMED
- Model / Reference
- 240006(S/UNI/Gray&Silver) EUDAMED240002(L/UNI/White) EUDAMED240002(XL/UNI/White) EUDAMED240006(L/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872869269 EUDAMED04719872861836 EUDAMED04719872861867 EUDAMED04719872869283 EUDAMED
- Basic UDI-DI
- 47198728624WE EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR 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
Jewett Hyperextension Brace 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 | 47198728624WE | 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 (4)
- EUDAMED 8f75f3cf-7d09-4160-8703-19b0dc1de976 61 fields · synced Oct 8, 2026
- EUDAMED f6b5e431-f148-480f-9625-be4c3055d348 61 fields · synced May 17, 2026
- EUDAMED ed0db15d-ecec-4ed3-ba3f-66ddae7271df 61 fields · synced May 19, 2026
- EUDAMED 7fa0d53b-a95f-43fa-855e-b60981f9982c 61 fields · synced May 19, 2026