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smart visual ear cleaner

by Heifeng Zhizao(Shenzhen)Technology Co., Ltd 3 variants

Ref R37RModel R1+ X3 X0 X1 Q3 D3 Pro Note5 Note5 Pro(refer to Declaration of Conformity for the complete models)

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697240382earmirrorEE Basic UDI-DI 06972403821879UDI-DIDate4 Jan 2024RegisteredStatusActive

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  • Withdrawn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
smart visual ear cleaner
Model / Reference
R1+ X3 X0 X1 Q3 D3 Pro Note5 Note5 Pro(refer to Declaration of Conformity for the complete models), R37R
Primary DI / UDI-DI
06972403821879
Basic UDI-DI
697240382earmirrorEE
EMDN Code
Q030499 Otology devices - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000038425
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Heifeng Zhizao(Shenzhen)Technology 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