Skip to content

Sup-Taper Files

by Shenzhen Rogin Medical Co., Ltd 100 variants

Ref R-P.01.01-025-VT-0A0-GD-000-00-00Model Sup-Taper Files Gold 25mm SX-F3 (SX,S1,S2,F1,F2,F3) 6pcs/blister

Active European Union

CE MDR CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06972214510344 Basic UDI-DI 06972214510344UDI-DIDate30 Jun 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06972214510344 Basic UDI-DI 06972214510344UDI-DIDate30 Jun 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Trade Name
Sup-Taper Files
Sup-Taper Files Gold 25mm SX-F3 6pcs/blister
Device Name
Rotary Root Canal Files
Model / Reference
Sup-Taper Files Gold 25mm SX-F3 (SX, S1, S2, F1, F2, F3) 6pcs/blister, R-P.01.01-025-VT-0A0-GD-000-00-00
Primary DI / UDI-DI
06972214510344
Basic UDI-DI
B-06972214510344, 6942007305NRGH
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU market of registration
Türkiye
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000012192
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen Rogin Medical Co., Ltd

See all devices from Shenzhen Rogin Medical Co., Ltd →

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