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Root Canal Files
EUDAMEDClass I (EU MDR)
Ref H05531Model Root Canal Files-for handRef SK00831Ref SK07028
Identity
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- Root Canal Files-for hand EUDAMEDH05531 EUDAMEDSK00831 EUDAMEDSK07028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957067056591 EUDAMED16957067051661 EUDAMED06957067056317 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 Files 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 (3)
- EUDAMED 9801e17c-e10c-4f69-8afe-0ccd6673cc0c 61 fields · synced Jul 25, 2026
- EUDAMED 1affb1e1-b0d5-41a5-b7b4-aa2b012a46f9 61 fields · synced May 17, 2026
- EUDAMED b7e965ab-e2d2-4e0d-b9c3-4a201181cebf 61 fields · synced May 17, 2026