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Fetal Doppler

by Shenzhen Unicare Electronic Co., Ltd.

Ref RD-R-QP008-002/A/0Model IMAMI-50, IMAMI-30, IMAMI-10, IMAMI-20

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69512176FDIMAMI50AK Basic UDI-DI Date28 Mar 2023RegisteredStatusActive

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  • Withdrawn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
IMAMI-50, RD-R-QP008-002/A/0, IMAMI-30, IMAMI-10, IMAMI-20
Primary DI / UDI-DI
16951217631031, 16951217631024, 16951217631000, 16951217631017
Basic UDI-DI
69512176FDIMAMI50AK, 69512176FDIMAMI30AD, 69512176FDIMAMI10A7, 69512176FDIMAMI20AA
EMDN Code
Z12080103 Foetal heartbeat detectors
Device Class
Class IIa
EU market of registration
Italy
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000032694
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Unicare Electronic 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