Identity
- Trade Name
- Helio EUDAMED
- Device Name
- Helio EUDAMED
- Model / Reference
- Helio EUDAMED15064 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430002080246 EUDAMED
- Basic UDI-DI
- 5430002080HelioYY EUDAMED
- Direct Marketing DI
- 05430002080246 EUDAMED
- EMDN Code
- V080603 TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Helio by Haelvoet NV — 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 | 5430002080HelioYY | Class I | Active |
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Manufacturer
- Manufacturer
- Haelvoet NV
- EUDAMED SRN
- BE-MF-000000056
Sources (1)
- EUDAMED 859b964f-fa51-4532-a8f3-8da7a1472e01 61 fields · synced Jul 13, 2026