Identity
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- HSHFI060221 EUDAMEDRFVOR200425 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979081656212 EUDAMED
- Basic UDI-DI
- 697908165DRCFRV EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Shenzhen Americuras Co., Ltd — 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 | 697908165DRCFRV | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Americuras Co., Ltd
- EUDAMED SRN
- CN-MF-000048352
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8aedd38b-4f71-43e7-8911-9f195cc9e7c1 61 fields · synced Jun 19, 2026