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Cardio Q70

by Bionet Co., Ltd.

Ref manyModel Cardio Q50 / Cardio Q70

Cardio Q70 (many) is an electrocardiograph (EU MDR Class IIa; FDA Class II) made by Bionet Co., Ltd., registered in EUDAMED on 19 Mar 2026 (Basic UDI-DI 880927694CQ57NE) with CE/MDR certificate 2024-MDR/QS-053/A valid until 12 Sep 2029, cleared under FDA 510(k) K231160 on 15 Dec 2023 and listed in FDA GUDID since 26 May 2026 (UDI-DI 08809276943965), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

12 Sep 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier 3EC International a.s.

510(k) K231160

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809276943965 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number880927694CQ57NE Basic UDI-DI 08809276943965UDI-DIDate19 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK231160 Date15 Dec 2023IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880927694CQ57NE registered 19 Mar 2026 Active· +1 more in the status table
  • FDA 510(k) K231160 decided 15 Dec 2023 Active
  • FDA GUDID UDI-DI 08809276943965 listed 26 May 2026 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-053/A Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Mar 2026
    Expires
    12 Sep 2029
    Reason
    Other

Timeline

5 dated events

  1. Cleared FDA 510(k) K231160
  2. Certificate issued EUDAMED 2024-MDR/QS-053/A
  3. Registered EUDAMED 880927694CQ57NE
  4. Listed FDA GUDID 08809276943965
  5. Certificate expires EUDAMED 2024-MDR/QS-053/A

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  • Withdrawn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

Trade name
Cardio Q70 EUDAMED
Cardio Q50, Cardio Q70 GUDID
Generic name
Electrocardiograph, professional, multichannel
Device name
Electrocardiographs & Spirometers
Model / reference
Cardio Q50 / Cardio Q70 EUDAMED
many EUDAMED
Cardio Q70 GUDID
Primary DI / UDI-DI
08809276943965
Basic UDI-DI
880927694CQ57NE
Direct marketing DI
08809276943965
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Cardio Q50 / Cardio Q70
many
GUDID
Cardio Q70
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.

Manufacturer details

EUDAMED SRN
KR-MF-000013439
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 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)