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Root Canal Files
EUDAMEDClass IIa (EU MDR)
Ref V02 2602 021 018Model V-TAPER ROTARY/V-TAPER GOLD/V-TAPER BLUE/V-TAPER NXT
Identity
- Device Name
- ROOT CANAL FILES EUDAMED
- Model / Reference
- V-TAPER ROTARY/V-TAPER GOLD/V-TAPER BLUE/V-TAPER NXT EUDAMEDV02 2602 021 018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974929766993 EUDAMED
- Basic UDI-DI
- 697492976V0006NE EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 Shanghai Fanta Dental Materials 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 | 697492976V0006NE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Fanta Dental Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000017176
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 91894d69-124b-4ffa-8699-8f11c28f2768 61 fields · synced Jun 19, 2026