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Dental Root Canal Rotary File

by Foshan Asin Dental Equipment Co., Limited 8 variants

Ref M3-G, U-files, M3-B, D-Files, S-Files, C-Files, DS-GModel DS-H,DS-RB,DS-G,DS-B,M3-RB,M3-G,M3-B,D-Files,H-Files,K-Files,R-Files,S-Files,U-files,C-Files

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697992946DRCRF001QL Basic UDI-DI Date19 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Dental Root Canal Rotary File
Model / Reference
DS-H, DS-RB, DS-G, DS-B, M3-RB, M3-G, M3-B, D-Files, H-Files, K-Files, R-Files, S-Files, U-files, C-Files
Primary DI / UDI-DI
06979929460339, 06979929460407, 06979929460346, 06979929460353, 06979929460391, 06979929460414, 06979929460308
Basic UDI-DI
697992946DRCRF001QL
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000052628
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Foshan Asin Dental Equipment Co., Limited

See all devices from Foshan Asin Dental Equipment Co., Limited →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: 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