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Root Canal instruments
EUDAMEDClass I (EU MDR)
Ref NTP02525Model Root Canal Files-for hand
Identity
- Trade Name
- Root Canal instruments EUDAMED
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- Root Canal Files-for hand EUDAMEDNTP02525 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957067071686 EUDAMED
- Basic UDI-DI
- 695706705118-5232NM EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Root Canal instruments by Innovative Material and Devices, Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 695706705118-5232NM | Class I | Active |
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Manufacturer
- Manufacturer
- Innovative Material and Devices, Inc
- EUDAMED SRN
- CN-MF-000002280
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED e9497692-a9d0-45be-8743-4cc814077f94 61 fields · synced Jun 18, 2026