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Fetal belt

by Dongguan Belcare Medical Technology Co., Ltd. 4 variants

Ref B01Model B01, pink and blue with button, 120*6cm B02, blue with button, 120*6cm B05, pink and blue with button, 150*6cm

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 Number697657112DCB001BW Basic UDI-DI 06976571120000UDI-DIDate23 Aug 2023RegisteredStatusActive

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  • Withdrawn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
Fetal belt
Model / Reference
B01, pink and blue with button, 120*6cm B02, blue with button, 120*6cm B05, 150*6cm
Primary DI / UDI-DI
06976571120000
Basic UDI-DI
697657112DCB001BW
EMDN Code
Z12030285 Vital signs monitoring instruments - consumables
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000035398
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Dongguan Belcare Medical Technology Co., Ltd.

See all devices from Dongguan Belcare Medical Technology Co., Ltd. →

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