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R-Shaper

by Shenzhen Rogin Medical Co., Ltd EUDAMED

Active European Union

Ref R-P.01.06-021-06-0S4-RB-000-00-00Model R-SHAPER (aurora version) 21mm S4(25/06) 6pcs/blister

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06942007305334 Basic UDI-DIDate7 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Model / Reference
R-SHAPER (aurora version) 21mm S4(25/06) 6pcs/blister, R-P.01.06-021-06-0S4-RB-000-00-00
Primary DI / UDI-DI
06942007305334
Basic UDI-DI
B-06942007305334
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
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