Cardiovit AT-102 G2

by Schiller AG

510(k) K183425Ref 3.912410

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183425↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number761336500000000758 Basic UDI-DI 07613365001860UDI-DI	Date20 Jan 2026Registered	StatusActive
United States	GUDID listing GUDID	Number07613365001860 UDI-DI	Date17 Apr 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK183425	Date2 Mar 2020Cleared	StatusActive

Official records

EUDAMED public site Basic UDI-DI 761336500000000758 — open Devices and search for it
AccessGUDID record UDI-DI 07613365001860
FDA 510(k) database 510(k) number K183425

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 761336500000000758 registered 20 Jan 2026 Active
FDA 510(k) K183425 decided 2 Mar 2020 Active
FDA GUDID UDI-DI 07613365001860 listed 17 Apr 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-2734-2024 FDA Class II initiated 24 Jul 2024
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

Timeline

4 dated events

2 Mar 2020 Cleared FDA 510(k) K183425
17 Apr 2020 Listed FDA GUDID 07613365001860
24 Jul 2024 Recall initiated FDA recalls Z-2734-2024
20 Jan 2026 Registered EUDAMED 761336500000000758

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name: Electrocardiograph, professional, multichannel
Model / reference: 3.912410

Primary DI / UDI-DI: 07613365001860
Basic UDI-DI: 761336500000000758
Direct marketing DI: 07613365001860
510(k) Number: K183425
FDA product code: DPS
EMDN code: Z12050301 General purpose electrocardiographs
GMDN term: Electrocardiograph, professional, multichannel

Device class: Class IIa EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 870.2340
EU registration type: Standard device
EU market of registration: Germany
Advisory committee: Cardiovascular
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Truth per registry

3 sources · 1 field differs

Field	EUDAMED	510(k)	GUDID
Device class	EUDAMED Class IIa	510(k) Class II	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 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cardiovit AT-102 G2 is a 12-channel electrocardiograph (ECG) device designed for recording and analyzing resting and exercise electrocardiograms. It provides real-time cardiac monitoring with high signal quality, supporting clinical assessments of cardiac function and rhythm disturbances.

This device is intended for use in general practitioner offices, clinics, and hospitals, featuring an 8-inch color touchscreen display and a sealed alphanumeric keyboard for easy cleaning and hygiene. Supplied as a reusable medical instrument, it complies with FDA 510(k) clearance and EU MDR regulations. Storage and maintenance follow manufacturer guidelines to ensure operational reliability.

Devices cleared under K183425

15 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K183425
		UDI-DI	Size and differences
CardioPulse Prime 3.912422 Schiller AG	98310 / 3.912422	07613365003772	Single use: no	No longer on the market
CARDIOVIT AT-102 G2 3.912410 Schiller AG	3.912410	07613365001860	Single use: no	On the market
CARDIOVIT AT-180 3.920570 Schiller AG	3.920570	07613365002775	Single use: no	On the market
Schiller ECG D-SUB B 2.0 x10 IEC 2.400180 Schiller AG	2.400180	07613365002232	Single use: no	On the market
Schiller ECG D-SUB C 3.5 x10 IEC 2.400175 Schiller AG	2.400175	07613365002201	Single use: no	On the market
SCHILLER ECG D-SUB2 B 3.1/2.55 x10 AHA Schiller AG	2.400187 / ECG D-SUB2 B 3.1/2.55 x10 AHA	07613365003956	Single use: no	On the market
SCHILLER ECG D-SUB2 B 3.1/2.55 x10 IEC Schiller AG	2.400186 / ECG D-SUB2 B 3.1/2.55 x10 IEC	07613365003949	Single use: no	On the market
SCHILLER ECG D-SUB2 B 3.5/3.1 x14 AHA Schiller AG	2.400336 / ECG D-SUB2 B 3.5/3.1 x14 AHA	07613365004229	Single use: no	On the market
SCHILLER ECG D-SUB2 B 3.5/3.1 x14 IEC Schiller AG	2.400335 / ECG D-SUB2 B 3.5/3.1 x14 IEC	07613365004212	Single use: no	On the market
SCHILLER ECG D-SUB2 C 3.5/3.1 x14 AHA Schiller AG	2.400334 / ECG D-SUB2 C 3.5/3.1 x14 AHA	07613365004205	Single use: no	On the market
SCHILLER ECG D-SUB2 C 3.5/3.1 x14 IEC Schiller AG	2.400333 / ECG D-SUB2 C 3.5/3.1 x14 IEC	07613365004199	Single use: no	On the market
SCHILLER ECG D-SUB2 C 4.6/4.25 x10 AHA Schiller AG	2.400185 / ECG D-SUB2 C 4.6/4.25 x10 AHA	07613365003932	Single use: yes	On the market
SCHILLER ECG D-SUB2 C 4.6/4.25 x10 IEC Schiller AG	2.400184 / ECG D-SUB2 C 4.6/4.25 x10 IEC	07613365003925	Single use: no	On the market
Schiller ECG EL-LT B 1.3/0.78 x4 IEC 2.410090 Schiller AG	2.410090	07613365003291	Single use: no	On the market
Schiller ECG EL-LT C 1.3/0.78 x4 IEC 2.410099 Schiller AG	2.410099	07613365003802	Single use: no	On the market

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Properties

Measuring function
Prescription use
Serial number
Manufacturing date

Other properties (21, all answered No)