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Otoscope

by Tianjin Bolang Science-Technology Development Co., Ltd. 32 variants

Ref ER029.100.WAModel ER02

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69477528ERJT Basic UDI-DI 06947752802480UDI-DIDate11 Sep 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  • Withdrawn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

Model / Reference
ER02, ER029.100.WA
Primary DI / UDI-DI
06947752802480
Basic UDI-DI
69477528ERJT
EMDN Code
Z12149006 Direct outpatient otoscopes
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008431
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Tianjin Bolang Science-Technology Development Co., Ltd.

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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