Cat-File
by Conception Et Fabrication De Produits Medicaux Et Paramedicaux France EUDAMED
Ref 3166779 Model Sterile Niti Engine Files
EMDN Q010507
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3665318FILE001NY | Date3 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 0425-MDR-030134-01 Issued
Quality management system EU MDR
- Notified body
- ICIM S.P.A. 0425
- Issued
- 15 Jun 2026
- Expires
- 29 Jun 2030
Specification
- Device Name
- Go-Taper Universal
- Model / Reference
- Sterile Niti Engine Files, 3166779
- Primary DI / UDI-DI
- 03665318027063
- Basic UDI-DI
- 3665318FILE001NY
- EMDN Code
- Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
- Device Class
- Class IIa
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000010345
Other devices from Conception Et Fabrication De Produits Medicaux Et Paramedicaux
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: 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 03665318027063|3665318FILE001NY