Identity
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- S-one EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973058893051 EUDAMED
- Basic UDI-DI
- 697305889305MW EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 Foshan SOCO Precision Instrument 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 | 697305889305MW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan SOCO Precision Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000008758
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 26de4659-6d52-45e3-906c-5a4477b20215 61 fields · synced Jul 13, 2026