Radiography X-Ray High Voltage Generator used in X-Ray Imaging System
EUDAMEDFDA UDIClass IIb (EU MDR)
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 EUDAMEDZR75PN65, Mini console with handswitch FDA UDI
- Model / Reference
- ZR75PN65 EUDAMEDFDA UDI
- Description
- ZR75PN65, Mini console with handswitch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975490630010 EUDAMEDFDA UDI
- Basic UDI-DI
- 697549063ZEUSVS EUDAMED
- Direct Marketing DI
- 06975490630010 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
No
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
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…
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 a00d9b55-b328-4417-8dce-5dc0c4cd9996 61 fields · synced Jul 21, 2026
- FDA UDI cc30feb6-b15c-4f8e-a2ab-5ea0917846f5 33 fields · synced May 30, 2026