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Cardio7

by Bionet Co., Ltd.

Ref manyModel Cardio7

Cardio7 is an electrocardiograph (EU MDR Class IIa; FDA Class II) made by Bionet Co., Ltd., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 880927694C72C), cleared under FDA 510(k) K113306 on 16 Jul 2012 and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 08809276943552), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K113306

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880927694C72C Basic UDI-DI 08809276943552UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809276943552 UDI-DI Date15 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113306 Date16 Jul 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880927694C72C registered 13 May 2026 Active
  • FDA 510(k) K113306 decided 16 Jul 2012 Active
  • FDA GUDID UDI-DI 08809276943552 listed 15 Jul 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113306
  2. Listed FDA GUDID 08809276943552
  3. Registered EUDAMED 880927694C72C

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Electrocardiograph, professional, multichannel
Device name
Electrocardiographs & Spirometers
Model / reference
Cardio7, many
Primary DI / UDI-DI
08809276943552
Basic UDI-DI
880927694C72C
Direct marketing DI
08809276943552
510(k) Number
FDA product code
DPS, BZG
EMDN code
Z12050301 General purpose electrocardiographs
GMDN term
Electrocardiograph, professional, multichannel
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2340, 868.1840
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: ST-segment electrocardiographic monitor

Similar devices

Also classified as ST-segment electrocardiographic monitor.

Similar devices in this category

Other devices filed under GENERAL PURPOSE ELECTROCARDIOGRAPHS.

Other devices from Bionet Co., Ltd.

See all devices from Bionet Co., Ltd. →

Properties

  • Measuring function
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)