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Electrocardiograph

by Bionet Co., Ltd.

Ref manyModel Cardio P1

Electrocardiograph (many) is a medical device (EU MDR Class IIa; FDA Class II; FDA product code DPS, Electrocardiograph; EMDN category general purpose electrocardiographs) made by Bionet Co., Ltd., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 880927694CP1SW), cleared under FDA 510(k) K231150 on 9 Nov 2023 and listed in FDA GUDID since 26 May 2026 (UDI-DI 08809276943972), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231150

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 Number08809276943972 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number880927694CP1SW Basic UDI-DI 08809276943972UDI-DIDate13 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231150 Date9 Nov 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880927694CP1SW registered 13 May 2026 Active
  • FDA 510(k) K231150 decided 9 Nov 2023 Active
  • FDA GUDID UDI-DI 08809276943972 listed 26 May 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231150
  2. Registered EUDAMED 880927694CP1SW
  3. Listed FDA GUDID 08809276943972

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  • Withdrawn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 P1
Generic name
Electrocardiograph, professional, multichannel
Model / reference
Cardio P1, many
Primary DI / UDI-DI
08809276943972
Basic UDI-DI
880927694CP1SW
Direct marketing DI
08809276943972
510(k) Number
FDA product code
DPS
EMDN code
Z12050301 General purpose electrocardiographs
GMDN term
Electrocardiograph, professional, multichannel
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2340
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.

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)