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S Spellman High Voltage Electronics Corporation
FDA UDIClass I (US FDA UDI)
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
- ZR75PN80, Touch screen console with handswitch FDA UDI
- Model / Reference
- ZR75PN80 FDA UDI
- Description
- ZR75PN80, Touch screen console with handswitch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975490630218 FDA UDI
- FDA Product Code
- IZO FDA UDI
- GMDN Term
- Diagnostic x-ray system generator, stationary FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Diagnostic x-ray system generator, stationary
S Spellman High Voltage Electronics Corporation by Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd — Class I — FDA UDI — listed in FDA GUDID
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 519a92e1-987f-4bae-ac72-27083fc1d7ab 33 fields · synced May 31, 2026