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Maramed Humerus Fracture Brace, XLarge, Left
EUDAMEDClass I (EU MDR)
Ref HFB-400L
Identity
- Trade Name
- Maramed Humerus Fracture Brace, XLarge, Left EUDAMED
- Device Name
- Maramed Humerus Fracture Brace EUDAMED
- Model / Reference
- HFB-400L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810050250184 EUDAMED
- Basic UDI-DI
- 081005025HFB63 EUDAMED
- Direct Marketing DI
- 00810050250184 EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER 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
Yes
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
Maramed Humerus Fracture Brace, XLarge, Left by BioSculptor Corporation — 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 | 081005025HFB63 | Class I | Active |
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Manufacturer
- Manufacturer
- BioSculptor Corporation
- EUDAMED SRN
- US-MF-000012686
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 6e12cfbe-da95-45e8-a9e1-cfa9756d0da6 61 fields · synced Jun 19, 2026