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proKlene Regular Prophylaxis Paste Medium Mint 50g

by Advanced Healthcare Ltd. 4 variants

Ref AH1426-T

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 Number5056009120039SE Basic UDI-DI 05060446609132UDI-DIDate17 Apr 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  • Withdrawn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
Oral Hygiene Products - Prophylaxis pastes
Model / Reference
AH1426-T
Primary DI / UDI-DI
05060446609132
Basic UDI-DI
5056009120039SE
EMDN Code
Q01010403 Dental abrasive and polishing materials
Device Class
Class I
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
GB-MF-000002771
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Advanced Healthcare Ltd.

See all devices from Advanced Healthcare 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