Identity
- Trade Name
- Maramed Sport Thumb Spica, Small, Left EUDAMED
- Device Name
- Maramed Thumb Spica Orthosis EUDAMED
- Model / Reference
- STS-100L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810050251099 EUDAMED
- Basic UDI-DI
- 081005025TSKU EUDAMED
- Direct Marketing DI
- 00810050251099 EUDAMED
- EMDN Code
- Y060606 HAND 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
Maramed Sport Thumb Spica, Small, 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 | 081005025TSKU | 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 158b6cb8-279e-44a1-8367-ed9554e84997 61 fields · synced Jul 9, 2026