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Sheetsplint™️ Universal Modular Splint
EUDAMEDClass I (EU MDR)
Ref S032MG2
by Ethr Oü
Identity
- Trade Name
- SHEETSPLINT™️ UNIVERSAL MODULAR SPLINT EUDAMED
- Device Name
- SHEETSPLINT™️ UNIVERSAL MODULAR SPLINT - 2 pcs. EUDAMED
- Model / Reference
- S032MG2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04745011024220 EUDAMED
- Basic UDI-DI
- 47450110242S032MG2K8 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Estonia 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
Category: Hand/finger splint, reusable
Sheetsplint™️ Universal Modular Splint by Ethr Oü — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 47450110242S032MG2K8 | Class I | Active |
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Manufacturer
- Manufacturer
- Ethr Oü
- EUDAMED SRN
- EE-MF-000032039
Sources (1)
- EUDAMED cb5d031f-8c02-4a15-95f5-a9feec48346b 61 fields · synced Jul 15, 2026