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ECG

by Suzhou Beneware Medical Equipment Co., Ltd. 3 variants

Ref CS-181-EN, CS-180-EN, CS-283-EN, CS-281-EN, CS-182-EN, CS-280-ENModel CS-181, CS-180, CS-283, CS-281, CS-182, CS-280

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-06958066402105 Basic UDI-DI Date21 Apr 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Rest/Stress exercise ECG systems
Model / Reference
CS-181, CS-181-EN, CS-180, CS-180-EN, CS-283, CS-283-EN, CS-281, CS-281-EN, CS-182, CS-182-EN, CS-280, CS-280-EN
Primary DI / UDI-DI
06958066402105, 06958066402099, 06958066402167, 06958066402143, 06958066402112, 06958066402136
Basic UDI-DI
B-06958066402105, B-06958066402099, B-06958066402167, B-06958066402143, B-06958066402112, B-06958066402136
EMDN Code
Z12050301 General purpose electrocardiographs
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000015853
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Suzhou Beneware Medical Equipment Co., Ltd.

See all devices from Suzhou Beneware Medical Equipment Co., Ltd. →

Properties

  • Measuring Function

Other properties (10)

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