Identity
- Trade Name
- Rotary Endo File EUDAMED
- Device Name
- Rotary Endo File EUDAMED
- Model / Reference
- P2- EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970602033482 EUDAMED
- Basic UDI-DI
- B-06970602033482 EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Rotary Endo File by Chengdu Sani Medical Equipment Co., Ltd — Class IIa — 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-06970602033482 | Class IIa | 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 20af31e0-b91b-43f9-b98f-761392bab3c0 61 fields · synced Jun 18, 2026