Identity
- Device Name
- DIAWIN D3 SERENE EUDAMED
- Model / Reference
- DIAWIN-D3-SERENE EUDAMEDFF45501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585074600872 EUDAMED
- Basic UDI-DI
- 85850746FF45T9 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 Serene 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 | 85850746FF45T9 | Class I | Active |
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Manufacturer
- Manufacturer
- Diawin s.r.o.
- EUDAMED SRN
- SK-MF-000048596
Sources (1)
- EUDAMED 6df57815-1793-4a1f-9aec-c34e0aee87d6 61 fields · synced Oct 6, 2026