Identity
- Device Name
- DIAWIN-D3-ETHEREAL EUDAMED
- Model / Reference
- DIAWIN-D3-ETHEREAL EUDAMEDFM40381 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585074600063 EUDAMED
- Basic UDI-DI
- 85850746FM40U2 EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Diawin-D3-Ethereal by Diawin s.r.o. — 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 | 85850746FM40U2 | Class I | Active |
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Manufacturer
- Manufacturer
- Diawin s.r.o.
- EUDAMED SRN
- SK-MF-000048596
Sources (1)
- EUDAMED 57d90444-9a15-41c7-9ad3-8537197ac495 61 fields · synced Jun 18, 2026