# CardioExpress 5012

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/cardioexpress-5012-many>
- Manufacturer: [Bionet Co., Ltd.](https://devicerts.com/manufacturers/bionet-co-ltd) (South Korea)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: BZG, DPS
- EMDN: Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS
- GMDN: Diagnostic spirometer, professional (13680)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 08809276944276 · listed 2026-05-26 · status: Listed (GUDID: in commercial distribution)
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 880927694CQ57NE · UDI-DI 08809276944276 · registered 2026-03-19 · status: Active
- **EUDAMED** · CE/MDR · European Union · 2024-MDR/QS-053/A · issued 2026-03-10 · expires 2029-09-12 · status: Active
- **GUDID** · FDA 510(k) · United States · K231160 · issued 2023-12-15 · status: Active · from GUDID

## EU certificates

- 2024-MDR/QS-053/A · Quality management system · MDR · notified body 3EC International a.s. · issued 2026-03-10 · expires 2029-09-12 · status: supplemented

## Recalls

No recall on record.

## Identity

- Trade name: CardioExpress 5012 [EUDAMED]; Cardio Q50, Cardio Q70 [FDA GUDID (AccessGUDID)]
- Generic name: Diagnostic spirometer, professional [FDA GUDID (AccessGUDID)]
- Device name: Electrocardiographs & Spirometers [EUDAMED]
- Model / reference: Cardio Q50 / Cardio Q70 [EUDAMED]; many [EUDAMED]; CardioExpress 5012 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08809276944276 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 880927694CQ57NE [EUDAMED]
- Direct marketing DI: 08809276944276 [EUDAMED]
- 510(k) Number: K231160 [FDA GUDID (AccessGUDID)]
- FDA product code: BZG [FDA GUDID (AccessGUDID)]; DPS [FDA GUDID (AccessGUDID)]
- EMDN code: Z12050301 [EUDAMED]
- GMDN term: Diagnostic spirometer, professional (13680) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 868.1840 [FDA GUDID (AccessGUDID)]; 870.2340 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: France [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Measuring function: Yes [EUDAMED]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: CardioExpress 5012, Bionet Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/cardioexpress-5012-many (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/cardioexpress-5012-many.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/cardioexpress-5012-many
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.