EnDrive
by Advanced Technology Research (A.T.R.) S:R.L. Italy EUDAMED
Ref EnDrive EMDN Q010199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805681427EnDriveJL | Date9 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 0425-MDR-030129-00 Issued
Quality management system EU MDR
- Notified body
- ICIM S.P.A. 0425
- Issued
- 14 Mar 2025
- Expires
- 13 Mar 2030
Specification
- Device Name
- EnDrive
- Model / Reference
- EnDrive
- Primary DI / UDI-DI
- 08056814270100
- Basic UDI-DI
- 805681427EnDriveJL
- EMDN Code
- Q010199 Conservative dentistry and endodontics devices - other
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000036666
Other devices from Advanced Technology Research (A.T.R.) S:R.L.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 1873001d-d4b4-49c7-bfd4-d3763f0b1258