Dxt-8l
Ref DXT-8LModel DXT-8M, DXT-10M, DXT-11M, DXT-12M, DXT-14U, DXT-15U, DXT-17U, DXT-19U, DXT-8L, DXT-11L, DXT-13L
Dxt-8l is a Class IIb device made by DRGEM Corporation, registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 88000111XT050086), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88000111XT050086 08800011105112 | Date2 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 88000111XT050086
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Rotating Anode X-ray Tube Assembly
- Model / reference
- DXT-8M, DXT-10M, DXT-11M, DXT-12M, DXT-14U, DXT-15U, DXT-17U, DXT-19U, DXT-8L, DXT-11L, DXT-13L
- Primary DI / UDI-DI
- 08800011105112
- Basic UDI-DI
- 88000111XT050086
- EMDN code
- Z11039012 X-ray tube assembly
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- KR-MF-000017990
- Authorised representative
- Obelis s.a. BE-AR-000000106
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