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SG522DR-Y

by Shenzhen SINO-K Medical Technology Co., Ltd.

Ref 07-10-00Model ECG

Active European Union

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/MDD NumberB-06972820963961 Basic UDI-DI 06972820963961UDI-DIDate9 Jun 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
ECG, 07-10-00
Primary DI / UDI-DI
06972820963961
Basic UDI-DI
B-06972820963961
EMDN Code
Z12050385 Electrocardiographs - consumables
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000021157
Authorised representative
Prolinx GmbH DE-AR-000005129

Related devices

Category: Electrocardiographic lead set, reusable

Other devices from Shenzhen SINO-K Medical Technology Co., Ltd

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Properties

  • Reusable
  • Administering Medicine
  • Measuring Function

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No