Identity
- Trade Name
- Dental root-canal Instruments EUDAMED
- Device Name
- Dental root-canal Instruments EUDAMED
- Model / Reference
- FFC2106AS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975495630961 EUDAMED
- Basic UDI-DI
- 697316311DRCI00001VF EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa 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
Dental root-canal Instruments by Suzhou Pac-Dent Technology Co., Ltd. — Class IIa — 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 | 697316311DRCI00001VF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Pac-Dent Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021642
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED d619b8a4-3ff2-4525-b0d4-580fe5c3f863 61 fields · synced Jun 19, 2026