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Maramed Over Shoulder Humerus Fracture Brace, Medium, Neutral
EUDAMEDClass I (EU MDR)
Ref HFB-OS-200
Identity
- Trade Name
- Maramed Over Shoulder Humerus Fracture Brace, Medium, Neutral EUDAMED
- Device Name
- Maramed Humerus Fracture Brace EUDAMED
- Model / Reference
- HFB-OS-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810050250313 EUDAMED
- Basic UDI-DI
- 081005025HFB63 EUDAMED
- Direct Marketing DI
- 00810050250313 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
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
Maramed Over Shoulder Humerus Fracture Brace, Medium, Neutral 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 69111219-8e97-4e85-b7cb-886960ee6a77 61 fields · synced Jul 30, 2026