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Optimal

by Guangzhou Berrcom Medical Device Co., Ltd. 7 variants

Ref ET106Model ET001, ET003, ET005, ET008, ET009, MD-H30, ET101, ET102, ET103, ET106, ET107, ET108

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 Number69476561ETXXX54 Basic UDI-DI 06947656119004UDI-DIDate15 Sep 2023RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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

Device Name
Ear Thermometer
Model / Reference
ET001, ET003, ET005, ET008, ET009, MD-H30, ET101, ET102, ET103, ET106, ET107, ET108
Primary DI / UDI-DI
06947656119004
Basic UDI-DI
69476561ETXXX54
Direct Marketing DI
06947656119004
EMDN Code
V0301010201 Contact digital thermometers (including probes)
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000013852
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Guangzhou Berrcom Medical Device Co., Ltd

See all devices from Guangzhou Berrcom Medical Device Co., Ltd →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No