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SRF618B6

by Guangzhou Sunray Medical Apparatus Co., Ltd.

Ref 069346679Model SRF618B6

Active European Union

CE MDR CE MDD

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 NumberB-06934667961357 Basic UDI-DI 06934667961357UDI-DIDate20 Sep 2022RegisteredStatusActive
European UnionCE/MDD NumberB-06934667961357 Basic UDI-DI 06934667961357UDI-DIDate20 Sep 2022RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Fetal Monitor
Model / Reference
SRF618B6, 069346679
Primary DI / UDI-DI
06934667961357
Basic UDI-DI
B-06934667961357, 69346679SRF1001ZT
Direct Marketing DI
06934667961357
EMDN Code
Z12080101 Foetal monitors
Device Class
Class IIa
EU market of registration
France
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000019807
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Guangzhou Sunray Medical Apparatus 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