Identity
- Trade Name
- EDITOR HFe 501 EUDAMEDEDITOR HFe FDA UDI
- Generic Name
- Diagnostic x-ray system generator, stationary FDA UDI
- Device Name
- EDITOR HFe EUDAMEDEDITOR HFe501 50kW, ALU UT 400VAC 3Ph. incl. DAP interface, prepared for HSS FDA UDI
- Model / Reference
- 082400105 EUDAMED501 FDA UDI
- Description
- EDITOR HFe501 50kW, ALU UT 400VAC 3Ph. incl. DAP interface, prepared for HSS FDA UDI
Identifiers
- Catalog Number
- 082400105 FDA UDI
- Primary DI / UDI-DI
- ESPN0824001050 EUDAMEDFDA UDI
- 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Diagnostic x-ray system generator, stationary
EDITOR HFe by Spellman High Voltage Electronics Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic x-ray system generator, stationary.
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- S Spellman High Voltage Electronics Corporation — Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spellman High Voltage Electronics Corp.
Sources (2)
- FDA UDI fd8886bf-a63f-46e4-af14-724f4623caeb 34 fields · synced Jul 12, 2026
- EUDAMED aca41789-e632-4989-b772-b6c2860cc4d3 61 fields · synced Jun 14, 2026