Identity
- Trade Name
- RO 1750 ROT 360 EUDAMEDFDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Device Name
- DXR-Glass Tubes Family EUDAMEDdiagnostic x-ray tube housing assembly FDA UDI
- Model / Reference
- 989000086112 EUDAMED9890-000-86112 FDA UDI
- Description
- diagnostic x-ray tube housing assembly FDA UDI
Identifiers
- Catalog Number
- 9890-000-86112 FDA UDI
- Primary DI / UDI-DI
- 00884838089952 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM495TK 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
Ro 1750 Rot 360 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 | 0884838BM495TK | 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 0268d7e4-1107-49ca-ba32-a9836c75ca7b 61 fields · synced Jul 23, 2026
- FDA UDI 80ee272b-e1f2-4f8e-ae3d-8482ce9d17c2 34 fields · synced May 30, 2026