Identity
- Trade Name
- CT XS Generator EUDAMEDFDA UDI
- Generic Name
- Diagnostic x-ray system generator, stationary FDA UDI
- Device Name
- XS Generator EUDAMEDX-ray control and HV generator FDA UDI
- Model / Reference
- 980605800118 EUDAMED9806-058-00118 FDA UDI
- Description
- X-ray control and HV generator FDA UDI
Identifiers
- Catalog Number
- 9806-058-00118 FDA UDI
- Primary DI / UDI-DI
- 00884838075931 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM501SM 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
- Netherlands 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
No
Category: Diagnostic x-ray system generator, stationary
CT XS Generator by Philips Medical Systems DMC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0884838BM501SM | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems DMC GmbH
- EUDAMED SRN
- DE-MF-000005362
Sources (2)
- EUDAMED 0fac951f-400c-4ca3-a5e5-43b7c7493a2c 61 fields · synced Jul 28, 2026
- FDA UDI 32a5e3ac-1124-486a-9275-95f7d7ff3770 34 fields · synced May 30, 2026