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FlexoDam Natural Rubber Latex Dental Dam

by Flexomatic Sdn Bhd

Ref DD200X-XX

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 Number955101458000826 Basic UDI-DI 09551014580008UDI-DIDate21 Jul 2024RegisteredStatusActive

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  • Withdrawn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
DD200X-XX
Primary DI / UDI-DI
09551014580008
Basic UDI-DI
955101458000826
EMDN Code
Q019002 Dentistry dams and hooks, single-use
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
MY-MF-000038792
Authorised representative
Advena SRL IT-AR-000051131

From the manufacturer

Manufacturer's product page: Hygiene Sheets (Oral Dams) (Natural Rubber Latex/Polyurethane)

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