Identity
- Trade Name
- Triniti® Rotary NiTi Files EUDAMED
- Device Name
- FlexMaster® EUDAMED
- Model / Reference
- V201357019000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +J003V2013570190001 EUDAMED
- Basic UDI-DI
- ++J00310145E8 EUDAMED
- Unit of Use DI
- +J003V2013570190000 EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Manual endodontic file/rasp, reusable
Triniti® Rotary NiTi Files by Maillefer Instruments Holding Sàrl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++J00310145E8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maillefer Instruments Holding Sàrl
- EUDAMED SRN
- CH-MF-000016301
- Authorised Representative
- Dentsply DeTrey GmbH DE-AR-000005904
Sources (1)
- EUDAMED ec72c2a1-e3e3-4225-a1ad-4841512a5b36 61 fields · synced Jul 27, 2026