Identity
- Trade Name
- XS-100 Generator EUDAMEDFDA UDI
- Generic Name
- Diagnostic x-ray system generator, stationary FDA UDI
- Device Name
- XS-100 Generator EUDAMEDX-ray control and HV generator FDA UDI
- Model / Reference
- 980605800224 EUDAMED9806-058-00224 FDA UDI
- Description
- X-ray control and HV generator FDA UDI
Identifiers
- Catalog Number
- 9806-058-00224 FDA UDI
- Primary DI / UDI-DI
- 00884838103788 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM502SP 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
XS-100 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 | 0884838BM502SP | 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 2e867971-663b-415f-842c-5f5314adaf9c 61 fields · synced Jul 21, 2026
- FDA UDI 75bbfc00-111c-489f-9ce9-00e07da85b8a 34 fields · synced May 30, 2026