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ECG Analysis System (and Spirometry)

by Zerone Co., Ltd.

Ref CZ-800

ECG Analysis System (and Spirometry) (CZ-800) is a medical device (EU MDD Class IIa; EMDN category general purpose electrocardiographs) made by Zerone Co., Ltd., registered in EUDAMED on 4 May 2026 (Basic UDI-DI B-08809417423028), active as of 22 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809417423028 Basic UDI-DI 08809417423028UDI-DIDate4 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
ECG (electrocardiographs)
Model / reference
CZ-800
Primary DI / UDI-DI
08809417423028
Basic UDI-DI
B-08809417423028
EMDN code
Z12050301 General purpose electrocardiographs
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000014148
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Similar devices in this category

Other devices filed under GENERAL PURPOSE ELECTROCARDIOGRAPHS.

Other devices from Zerone Co., Ltd.

See all devices from Zerone Co., Ltd. →

Properties

Other properties (12, all answered No)