← Back to catalogue
EDITOR HFe 401
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 082480104Ref 081480104Ref 031400104-BA6Ref 31400104Ref 082400104Ref 032400204-24VRef 031230104-BA-MRef 031400104-24VRef 032400104-MRef 091400104-ZAP
Identity
- Trade Name
- EDITOR HFe 401 EUDAMEDEDITOR HFe FDA UDI
- Generic Name
- Diagnostic x-ray system generator, stationary FDA UDI
- Device Name
- EDITOR HFe EUDAMEDEDITOR HFe401 40kW, ALU UT 480VAC 3Ph. incl. DAP interface FDA UDIEDITOR HFe401 40kW, ALU UT 400VAC 3Ph. incl. DAP interface FDA UDI
- Model / Reference
- 082480104 EUDAMED081480104 EUDAMED031400104-BA6 EUDAMED31400104 EUDAMED082400104 EUDAMED032400204-24V EUDAMED031230104-BA-M EUDAMED031400104-24V EUDAMED032400104-M EUDAMED091400104-ZAP EUDAMED401 FDA UDI
- Description
- EDITOR HFe401 40kW, ALU UT 480VAC 3Ph. incl. DAP interface FDA UDIEDITOR HFe401 40kW, ALU UT 400VAC 3Ph. incl. DAP interface FDA UDI
Identifiers
- Catalog Number
- 082480104 FDA UDI082400104 FDA UDI
- Primary DI / UDI-DI
- ESPN0824801040 EUDAMEDFDA UDIESPN0824001040 EUDAMEDFDA UDIESPN0814801040 EUDAMEDESPN031400104BA60 EUDAMEDESPN0314001040 EUDAMEDESPN03240020424V0 EUDAMEDESPN031230104BAM0 EUDAMEDESPN03140010424V0 EUDAMEDESPN032400104M0 EUDAMEDESPN091400104ZAP0 EUDAMED
- Basic UDI-DI
- ++ESPNEDITORHFe23 EUDAMED
- FDA Product Code
- IZO FDA UDI
- EMDN Code
- Z11039011 HIGH VOLTAGE X-RAY GENERATORS EUDAMED
- GMDN Term
- Diagnostic x-ray system generator, stationary FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1700 FDA UDI
- Market of Registration
- Austria EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic x-ray system generator, stationary
EDITOR HFe 401 by Spellman High Voltage Electronics GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++ESPNEDITORHFe23 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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 (12)
- EUDAMED 3b38e174-c4f6-43c3-9d36-701c734e84c7 61 fields · synced Sep 17, 2026
- FDA UDI dd98e0e2-b8a4-47d6-9930-badf15e36f54 34 fields · synced May 30, 2026
- FDA UDI 5466d2a0-62e1-4f54-bd10-8da246ce6876 34 fields · synced May 30, 2026
- EUDAMED b2c75021-b29f-4c29-b69d-ecb79702d2f0 61 fields · synced Jul 9, 2026
- EUDAMED 480db4f3-8d8b-4591-9c96-53ab2906f171 61 fields · synced Jul 10, 2026
- EUDAMED b719dd53-6eab-44d9-9d87-f2f66d3d0666 61 fields · synced Jul 11, 2026
- EUDAMED 77618b14-0614-4e3a-863c-f59cc97b879c 61 fields · synced Jul 14, 2026
- EUDAMED 57cd726b-86c3-4d35-9ddf-7cbf3ecc0ec1 61 fields · synced Jul 16, 2026
- EUDAMED ae5b1a70-6b84-401b-a808-634cfdd2955c 61 fields · synced Jul 17, 2026
- EUDAMED a3620298-0ab1-46d9-990c-abd97ca055fe 61 fields · synced Jul 22, 2026
- EUDAMED a2701b05-7ead-4b43-9461-85523e2587a1 61 fields · synced Aug 3, 2026
- EUDAMED 9bd55779-f595-4aa3-be3d-5be7a947ce76 61 fields · synced Sep 17, 2026