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Bite block covers

by Snowdent Healthcare Co., Ltd 6 variants

Ref BC02Model BC01、BC02、BC03、BC04、009S、009M、 009L、145、BC05-3D、BC06-3D、Customized

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697999994sleeve431BB Basic UDI-DIDate24 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  • Withdrawn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
Disposable Barrier Sleeves/Covers/Film
Model / Reference
BC01、BC02、BC03、BC04、009S、009M、 009L、145、BC05-3D、BC06-3D、Customized, BC02
Primary DI / UDI-DI
06979999944326
Basic UDI-DI
697999994sleeve431BB
EMDN Code
Q010599 Dental instruments, single-use - other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008775
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Snowdent Healthcare Co., Ltd

See all devices from Snowdent Healthcare Co., 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