Quality and Regulatory Compliance

Labtech Kft. is committed to maintaining a high level of product quality, safety and regulatory compliance.

All Labtech Kft. products are designed, manufactured, distributed and serviced within a Quality Management System certified in accordance with ISO 13485:2016.

Certificates

Quality Management System

Notified Body:
DQS Medizinprodukte GmbH – 0297
Certificate No. / Issue date:
1000225474 / 11 May 2025

View ISO 13485 Certificate

MDD Legacy Devices

Our legacy devices categorized in EC type Holter systems with ‘CARDIOSPY’ software and EC type resting and stress Test ECG systems with ‘CARDIOSPY’ software noninvasive cardiologic measuring equipment family, including all applicable accessories, meet the requirements of the transitional provisions under Article 120 of Regulation (EU) 2017/745 of the European Parliament and of the Council (MDR), as amended by Regulation (EU) 2023/607, applicable to legacy devices certified under Directive 93/42/EEC (MDD).

Notified Body issuing the MDD Certificate:
NEOEMKI National Medical Device Conformity Assessment and Certification LLC – 1011
MDD Certificate No. / Issue date:
5-850-200-1806 / 28 July 2020
Notified Body issuing the Confirmation Letter:
DQS Medizinprodukte GmbH – 0297
Confirmation Letter reference / Issue date:
1000179490 / 24 October 2024

View MDD CertificateView Confirmation Letter

MDR-Certified V6 Medical Devices

The V6 new generation of the medical devices and accessories categorized in EC type Holter systems and EC type resting and stress test ECG systems meet the applicable requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (MDR).

Notified Body:
DQS Medizinprodukte GmbH – 0297
Certificate No. / Issue date:
1000202833 / 30 April 2026

View MDR Certificate

FDA 510(k) Clearance

Labtech ECG Holter systems have received U.S. FDA 510(k) clearance under K140847.

510(k) Number:
K140847

View FDA 510(k) Record