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R-Shaper Files

by Shenzhen Rogin Medical Co., Ltd 54 variants

Ref R-P.01.06-025-04-0S1-BU-000-00-01Model R-Shaper Files Blue 25mm 20/04 6pcs/blister

Active European Union

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06942007308762 Basic UDI-DI 06942007308762UDI-DIDate9 Jul 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
R-Shaper Files Blue 25mm 20/04 6pcs/blister, R-P.01.06-025-04-0S1-BU-000-00-01
Primary DI / UDI-DI
06942007308762
Basic UDI-DI
B-06942007308762
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU market of registration
Türkiye

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 (11)

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