Identity
- Trade Name
- XS-100 X-Ray Tube Assembly EUDAMEDFDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Device Name
- XS-OEMTubes Family EUDAMEDdiagnostic x-ray tube housing assembly FDA UDI
- Model / Reference
- 980605800543 EUDAMED9806-058-00543 FDA UDI
- Description
- diagnostic x-ray tube housing assembly FDA UDI
Identifiers
- Catalog Number
- 9806-058-00543 FDA UDI
- Primary DI / UDI-DI
- 00884838103634 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM497TP EUDAMED
- FDA Product Code
- ITY FDA UDI
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY EUDAMED
- GMDN Term
- X-ray tube housing assembly, diagnostic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1760 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
XS-100 X-Ray Tube Assembly by Philips Medical Systems DMC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0884838BM497TP | 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 37996574-7a93-4f32-a617-d7759b22caeb 61 fields · synced Jun 9, 2026
- FDA UDI ea1f6d2d-e627-404d-89b3-80e5f7b5fe30 34 fields · synced May 30, 2026