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Root Canal Files

by Shanghai Fanta Dental Materials Co., Ltd 80 variants

Ref A06 2606 016 030Model AF ROTARY/AF BLUE ROTARY/AF BLUE R3/AF BABY/AF BLUE S ONE/AF F ONE/AF F ONE BLUE/AF PRO GOLD/RISING ROTARY FILE/HARMONY ROTARY FILE/R ONE MINI KIT

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697492976A0006F7 Basic UDI-DI 06974929764579UDI-DIDate28 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Root Canal Files
Model / Reference
AF ROTARY/AF BLUE ROTARY/AF BLUE R3/AF BABY/AF BLUE S ONE/AF F ONE/AF F ONE BLUE/AF PRO GOLD/RISING ROTARY FILE/HARMONY ROTARY FILE/R ONE MINI KIT, A06 2606 016 030
Primary DI / UDI-DI
06974929764579
Basic UDI-DI
697492976A0006F7
EMDN Code
L159004 Endodontic rasps and files, reusable
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000017176
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

From the manufacturer

Manufacturer's product page: Root Canal Files

Other devices from Shanghai Fanta Dental Materials Co., Ltd

See all devices from Shanghai Fanta Dental Materials Co., Ltd →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No