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Maramed Ulna Fracture Brace, Medium, Right
EUDAMEDClass I (EU MDR)
Ref UFB-200R
Identity
- Trade Name
- Maramed Ulna Fracture Brace, Medium, Right EUDAMED
- Device Name
- Maramed Ulna Fracture Brace EUDAMED
- Model / Reference
- UFB-200R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810050251372 EUDAMED
- Basic UDI-DI
- 081005025UFB84 EUDAMED
- Direct Marketing DI
- 00810050251372 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 Ulna Fracture Brace, Medium, Right 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 | 081005025UFB84 | 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 18ff3381-ae3a-455b-9352-15c31aac2843 61 fields · synced Jun 19, 2026