Identity
- Device Name
- Root Canal File EUDAMED
- Model / Reference
- N/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970602030184 EUDAMED
- Basic UDI-DI
- B-06970602030184 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Root Canal File by Chengdu Sani Medical Equipment Co., Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970602030184 | Class I | Active |
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Manufacturer
- Manufacturer
- Chengdu Sani Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000011715
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 95830231-2e0f-432e-b7a5-d1e7f5440aa2 61 fields · synced Jun 19, 2026