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Otoscope

by Zhejiang Honsun Medical Technology Co., Ltd

Ref HS-OT10Model HS-OT10,HS-OT10A,HS-OT10B,HS-OT10C, HS-OT10D,HS-OT10E,HS-OT10F, HS-OT10G,HS-OT10H,HS-OT10I, HS-OT10J,HS-OT10K,HS-OT10L, HS-OT10L-C,HS-OT10L-C2,HS-OT10M, HS-OT10N, HS-OT10P,HS-OT10Q, HS-OT10R,HS-OT10S,HS-OT10T, HS-OT10U,HS-OT10W,HS-OT10X, HS-OT10Y,HS-OT10Z

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697254509OTOSCOPETY Basic UDI-DI 06972545091000UDI-DIDate30 Mar 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  • Withdrawn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
Otoscope
Model / Reference
HS-OT10, HS-OT10A, HS-OT10B, HS-OT10C, HS-OT10D, HS-OT10E, HS-OT10F, HS-OT10G, HS-OT10H, HS-OT10I, HS-OT10J, HS-OT10K, HS-OT10L, HS-OT10L-C, HS-OT10L-C2, HS-OT10M, HS-OT10N, HS-OT10P, HS-OT10Q, HS-OT10R, HS-OT10S, HS-OT10T, HS-OT10U, HS-OT10W, HS-OT10X, HS-OT10Y, HS-OT10Z
Primary DI / UDI-DI
06972545091000
Basic UDI-DI
697254509OTOSCOPETY
EMDN Code
Z12149006 Direct outpatient otoscopes
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039480
Authorised representative
Sungo Cert GmbH DE-AR-000010869

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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