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Teeth Whitening Gel

by Zhengzhou Huaer Electro-optics Technology Co, Ltd.

Ref 06974041280698Model HR-BSG01,HR-BSG02,HR-BSG03,HR-BSG04,HR-BPG01,HR-BPG02,HR-BPG03,HR-BPG04,HR-BPG05

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 Number697404128TWG001LA Basic UDI-DI 06974041280698UDI-DIDate14 Apr 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  • Withdrawn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
Teeth Whitening Gel
Model / Reference
HR-BSG01, HR-BSG02, HR-BSG03, HR-BSG04, HR-BPG01, HR-BPG02, HR-BPG03, HR-BPG04, HR-BPG05, 06974041280698
Primary DI / UDI-DI
06974041280698
Basic UDI-DI
697404128TWG001LA
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000003166
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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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