Identity
- Trade Name
- EDITOR HFe 601 EUDAMED
- Device Name
- EDITOR HFe EUDAMED
- Model / Reference
- 07002303-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ESPN070023030020 EUDAMED
- Basic UDI-DI
- ++ESPNEDITORHFe23 EUDAMED
- EMDN Code
- Z11039011 HIGH VOLTAGE X-RAY GENERATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
EDITOR HFe 601 by Spellman High Voltage Electronics GmbH — Class IIb — 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 | ++ESPNEDITORHFe23 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Spellman High Voltage Electronics GmbH
- EUDAMED SRN
- DE-MF-000014609
Sources (1)
- EUDAMED 2d1aa2cd-e4d0-44ab-ae11-670af1fa8cfd 61 fields · synced Aug 4, 2026