Skip to content

SPO2 Sensor

by Shenzhen Coreray Technology Co., Ltd. 3 variants

Ref CR003-5302AD, CR001, CR003-5302ACModel CR001-5303A

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06928737835518 Basic UDI-DI Date10 May 2024RegisteredStatusActive
European UnionCE/MDD NumberB-06928737835518 Basic UDI-DI Date10 May 2024RegisteredStatusActive

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  • Withdrawn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
SPO2 Sensor
Model / Reference
CR003-5302AD, CR001-5303A, CR001, CR003-5302AC
Primary DI / UDI-DI
06928737835518, 06928737831633, 06928737835501
Basic UDI-DI
B-06928737835518, 69287378CR001RM, B-06928737835501
EMDN Code
Z12030285 Vital signs monitoring instruments - consumables
Device Class
Class IIb
EU market of registration
Northern Ireland
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000018015
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Coreray Technology, Ltd.

See all devices from Shenzhen Coreray Technology, 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