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Radiography X-Ray High Voltage Generator used in X-Ray Imaging System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ZR75PN50
by Spellman High Voltage Electronics (Suzhou Industrial Park) Co., Ltd
Identity
- Trade Name
- S Spellman High Voltage Electronics Corporation FDA UDI
- Generic Name
- Diagnostic x-ray system generator, stationary FDA UDI
- Device Name
- Radiography X-Ray High Voltage Generator used in X-Ray Imaging System EUDAMEDZR75PN50, Without console FDA UDI
- Model / Reference
- ZR75PN50 EUDAMEDFDA UDI
- Description
- ZR75PN50, Without console FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975490630164 EUDAMEDFDA UDI
- Basic UDI-DI
- 697549063ZEUSVS EUDAMED
- Direct Marketing DI
- 06975490630164 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
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
No
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
Radiography X-Ray High Voltage Generator used in X-Ray Imaging System by Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd — Class IIb — MDR…
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 | 697549063ZEUSVS | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000025423
- Authorised Representative
- Spellman High Voltage Electronics GmbH DE-AR-000019248
Sources (2)
- EUDAMED a8dcf32e-d754-4413-a18e-edcdf2b6b43f 61 fields · synced Jul 21, 2026
- FDA UDI 7e278b04-911e-47f7-82de-a8adfc45096b 33 fields · synced May 30, 2026