Identity
- Trade Name
- EDITOR HFe 501 EUDAMED
- Device Name
- EDITOR HFe EUDAMED
- Model / Reference
- 033400105-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- ESPN033400105M0 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
Category: Diagnostic x-ray system generator, stationary
EDITOR HFe 501 by Spellman High Voltage Electronics GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic x-ray system generator, stationary.
- SEDECAL — Sedecal., Sa. · Class I
- QG-32-SE — CARESTREAM HEALTH, INC. · Class I
- SEDECAL — Sedecal., Sa. · Class I
- QG-50-2 — CARESTREAM HEALTH, INC. · Class I
- SEDECAL — Sedecal., Sa. · Class I
- S Spellman High Voltage Electronics Corporation — Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd · Class I
- iRay — Iray Imaging Technology (Haining) Limited · Class I
- SEDECAL — Sedecal., Sa. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spellman High Voltage Electronics GmbH
- EUDAMED SRN
- DE-MF-000014609
Sources (1)
- EUDAMED 3cf194b6-a9ba-4fe8-93f1-3d9bba38c25c 61 fields · synced Aug 4, 2026