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Lumbar Decompression Back Brace
EUDAMEDClass I (EU MDR)
Ref B011 Model Trunk Orthoses
Identity
- Trade Name
- Lumbar Decompression Back Brace EUDAMED
- Model / Reference
- Trunk Orthoses EUDAMEDB011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867216039 EUDAMED
- Basic UDI-DI
- 697886721TO000TV EUDAMED
- Direct Marketing DI
- 06978867216039 EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Decompression Back Brace by Medi Global Assistive Device 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 | 697886721TO000TV | Class I | Active |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 6528494d-c2f8-4319-b4e4-8884dfee6925 61 fields · synced Jul 17, 2026