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High speed air turbine handpiece

by Bestdent Foshan Medical Equipment CO., Ltd 45 variants

Ref 201C4

Active European Union

CE MDR

Valid until

23 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

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 NumberCN26/00004548 Date23 Jun 2026IssuedStatusActive EUDAMED: not on the EU market expires 23 Jun 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN26/00004548 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    23 Jun 2026
    Expires
    23 Jun 2031

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
201C4
Primary DI / UDI-DI
16971321490164
Basic UDI-DI
697132149HSATHJE
EMDN Code
Z12110102 Dental drills
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000002181
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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