Identity
- Device Name
- DIAWIN D3 PURE EUDAMED
- Model / Reference
- DIAWIN-D3-PURE EUDAMEDFM42422 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585074602449 EUDAMED
- Basic UDI-DI
- 85850746FM42U6 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 Pure 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 | 85850746FM42U6 | Class I | Active |
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Manufacturer
- Manufacturer
- Diawin s.r.o.
- EUDAMED SRN
- SK-MF-000048596
Sources (1)
- EUDAMED 9f5399bd-dfd1-49de-9e22-bb44bc349b01 61 fields · synced Jun 19, 2026