Identity
- Trade Name
- SRM 0612 ROT 500 EUDAMEDFDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Device Name
- DXR-Glass Tubes Family (MDD) EUDAMEDdiagnostic x-ray tube housing assembly FDA UDI
- Model / Reference
- 989000063901 EUDAMED9890-000-63901 FDA UDI
- Description
- diagnostic x-ray tube housing assembly FDA UDI
Identifiers
- Catalog Number
- 9890-000-63901 FDA UDI
- Primary DI / UDI-DI
- 00884838076105 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838076105 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Srm 0612 Rot 500 by Philips Medical Systems DMC GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838076105 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems DMC GmbH
- EUDAMED SRN
- DE-MF-000005362
Sources (2)
- EUDAMED 8eee38c7-5d08-4845-999b-e8a7551c1555 61 fields · synced Jun 19, 2026
- FDA UDI ebcdad54-b8bd-4e61-97ed-2ec77b0a3a15 34 fields · synced May 29, 2026