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SZcaremed

by Shenzhen Caremed Medical Technology Co., Ltd. 188 variants

Ref F2D-PK22B

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 Number69707585F201R4 Basic UDI-DI Date3 Aug 2026RegisteredStatusActive

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  • Withdrawn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
F2D-PK22B
Primary DI / UDI-DI
06931973459936, 16931973400010
Basic UDI-DI
69707585F201R4
Direct Marketing DI
06931973459936
EMDN Code
U100299 Foetal study devices - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000010579
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Caremed Medical Technology Co., Ltd.

See all devices from Shenzhen Caremed 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