Identity
- Trade Name
- Helioform H Elektrolyt EUDAMEDHelioform H Elektrolyt für HF 700 EUDAMED
- Device Name
- Galvanoprodukte EUDAMED
- Model / Reference
- 8281 EUDAMED7837 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251936500898 EUDAMED04251936500881 EUDAMED
- Basic UDI-DI
- 425193650000000002X5 EUDAMED
- Direct Marketing DI
- 04251936500898 EUDAMED04251936500881 EUDAMED
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Category: Dental casting non-noble alloy
Helioform H Elektrolyt by C.HAFNER GmbH + Co. KG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 425193650000000002X5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- C.HAFNER GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000006304
Sources (2)
- EUDAMED 8abca021-e464-4345-996c-db9ac49ac8b5 61 fields · synced Jul 30, 2026
- EUDAMED 06d700aa-dcd5-4b42-9377-71910785767c 61 fields · synced May 17, 2026