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CB11 A1

by Hangzhou SHINING3D Dental Technology Co., Ltd.

Ref 0691Model CB11

Active European Union

CE MDR

Valid until

23 Apr 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BUREAU VERITAS ITALIA S.P.A.

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 Number697533870CB11JA Basic UDI-DI 06975338700691UDI-DIDate9 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Temporary CB Resin
Model / Reference
CB11, 0691
Primary DI / UDI-DI
06975338700691
Basic UDI-DI
697533870CB11JA
Direct Marketing DI
06975338700691
EMDN Code
Q0102050101 Temporary teeth resins
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000033456
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