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TopFlex Dental Irrigation Tips

by Shenzhen Rogin Medical Co., Ltd

Ref R-P.13.03-3004-Y02-CEK-KD-00

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6942007309ITGS Basic UDI-DI 06942007315302UDI-DIDate7 Jul 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  • Withdrawn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

Model / Reference
R-P.13.03-3004-Y02-CEK-KD-00
Primary DI / UDI-DI
06942007315302
Basic UDI-DI
6942007309ITGS
EMDN Code
Q019006 Dental material application tips and brushes, single-use
Device Class
Class I
EU market of registration
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

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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