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Tbaiwell

by Guangzhou Itingbaby Tech CO., Ltd.

Ref TB.FM.BP130Model TB.FM.BP130,TB.FM.BB130,TB.FM.BP140,TB.FM.CC130,TB.FM.150,TB.FM.R01,FM.R02,FM.R03

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 Number697366101TBFMMG Basic UDI-DI 06973661011019UDI-DIDate12 Mar 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  • Withdrawn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

Device Name
Fetal Monitoring Belts/ CTG Belts
Model / Reference
TB.FM.BP130, TB.FM.BB130, TB.FM.BP140, TB.FM.CC130, TB.FM.150, TB.FM.R01, FM.R02, FM.R03
Primary DI / UDI-DI
06973661011019
Basic UDI-DI
697366101TBFMMG
EMDN Code
Z12030285 Vital signs monitoring instruments - consumables
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000040579
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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