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Otoscope

by Wuzhou Aokace Technology Co., Ltd. 5 variants

Ref E304BGModel E005BG、E305BG、E004BG、E304BG、E003BG

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 linked in EUDAMED

A group certificate may exist

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 Number697546580OEBGRH Basic UDI-DI 06975465800349UDI-DIDate20 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
E005BG、E305BG、E004BG、E304BG、E003BG, E304BG
Primary DI / UDI-DI
06975465800349
Basic UDI-DI
697546580OEBGRH
EMDN Code
Z12021003 Laryngoscopes
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000027213
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Laryngoscope blade, reusable

Other devices from Wuzhou Aokace Technology Co., Ltd.

See all devices from Wuzhou Aokace Technology Co., Ltd. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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