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BraceID-Lumbo Sacral Orthosis - XLarge
EUDAMEDClass I (EU MDR)
Ref 12-0081-2Model 11-0081-S
by Orthobroker
Identity
- Trade Name
- BraceID-Lumbo Sacral Orthosis - XLarge EUDAMED
- Device Name
- Contoured Back Support Black - Small EUDAMED
- Model / Reference
- 11-0081-S EUDAMED12-0081-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404020402168 EUDAMED
- Basic UDI-DI
- 5404020402trunkheadce5B EUDAMED
- EMDN Code
- Y060318 CERVICOTHORACOLUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
BraceID-Lumbo Sacral Orthosis - XLarge by Orthobroker — 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 | 5404020402trunkheadce5B | Class I | Active |
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Manufacturer
- Manufacturer
- Orthobroker
- EUDAMED SRN
- BE-MF-000000331
Sources (1)
- EUDAMED 9aeb29ae-777d-4602-90a7-16badd4d84c5 61 fields · synced Jun 18, 2026