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Helena - Adjustable-Width Shoes - Khaki- Size 37
EUDAMEDClass I (EU MDR)
Ref 4978079037Model HELENA-KAKI
by Neut
Identity
- Trade Name
- HELENA - ADJUSTABLE-WIDTH SHOES - KHAKI- SIZE 37 EUDAMED
- Model / Reference
- HELENA-KAKI EUDAMED4978079037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664588039172 EUDAMED
- Basic UDI-DI
- 3664588HELENA906D EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Helena - Adjustable-Width Shoes - Khaki- Size 37 by Neut — 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 | 3664588HELENA906D | Class I | Active |
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Manufacturer
- Manufacturer
- Neut
- EUDAMED SRN
- FR-MF-000009582
Sources (1)
- EUDAMED 47059ab6-14e5-447d-a030-847847d04868 61 fields · synced Jun 19, 2026