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Dr.mayer

by Bi̇lki̇m Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Ltd.şti̇.

Ref 321DRMModel 321

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 Number869898070BLKMMDLMTE Basic UDI-DI 08698980700366UDI-DIDate27 Aug 2025RegisteredStatusActive

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  • Withdrawn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
Polywax Orthodontic Wax
Model / Reference
321, 321DRM
Primary DI / UDI-DI
08698980700366
Basic UDI-DI
869898070BLKMMDLMTE
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
TR-MF-000030602

Other devices from Bi̇lki̇m Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Ltd.şti̇.

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