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Rx Dc
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 706RModel Dental intraoral x-ray equipmentRef 706T, 706X510(k) K163519Ref 706QRef 706M, 706N
by CEFLA s.c.
Identity
- Trade Name
- RX DC EUDAMED
- Model / Reference
- Dental intraoral x-ray equipment EUDAMED706R EUDAMED706T, 706X EUDAMED706Q EUDAMED706M, 706N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837936169 EUDAMED08033837936114 EUDAMED08033837936152 EUDAMED08033837936138 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYINB001R6 EUDAMED
- Direct Marketing DI
- 08033837936169 EUDAMED08033837936114 EUDAMED08033837936152 EUDAMED08033837936138 EUDAMED
- EMDN Code
- Z1103040101 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Rx Dc by CEFLA s.c. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163519 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 803383793IMXRAYINB001R6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (7)
- EUDAMED 5be9397e-8c3b-4fc2-a7e5-cb10421d2fa1 61 fields · synced Aug 2, 2026
- EUDAMED fd26e3d1-6609-4eaf-b717-fd0bbf3635c4 85 fields · synced May 11, 2026
- EUDAMED 49acb1f4-fd5c-47ff-88ac-fac4e1e4a22e 61 fields · synced May 18, 2026
- EUDAMED fd26e3d1-6609-4eaf-b717-fd0bbf3635c4-1 61 fields · synced Jul 24, 2026
- EUDAMED 6fb13ba0-3792-4181-ab64-820ec9e3903f-1 61 fields · synced Aug 2, 2026
- EUDAMED 6fb13ba0-3792-4181-ab64-820ec9e3903f-2 61 fields · synced Aug 2, 2026
- FDA 510(k) K163519 1 fields · synced May 18, 2026