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SanctuaryTM 165mm X 130mm Latex Pre-Framed Dental Dam-Blue Medium Plain

by Sanctuary Health Sdn Bhd

Ref PL122B-FASH0

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 Number955551401LPDSH02QF Basic UDI-DI 09555514009441UDI-DIDate5 Oct 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  • Withdrawn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
SanctuaryTM Latex Pre-Framed Dental Dam
Model / Reference
PL122B-FASH0
Primary DI / UDI-DI
09555514009441
Basic UDI-DI
955551401LPDSH02QF
Direct Marketing DI
09555514009441
EMDN Code
Q019002 Dentistry dams and hooks, single-use
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
MY-MF-000002197
Authorised representative
Wellkang Ltd XI-AR-000001836

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Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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