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. 

CE Marking
Our medical devices are CE marked in accordance with the applicable European regulatory requirements.

Certificates 

Quality Management System 

Notified Body:
DQS Medizinprodukte GmbH – 0297 

Certificate No. / Issue date:
1000225474 / 11 May 2025 

ISO 13485- Labtech Kft -2025-05-11_31623209 – MP2021

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 

CE_Certificate_5-850-200-1806_EMKI 2517

DQS Confirmation Letter acc. to regulation EU 2023_607_Labtech Kft_31623209 signed

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 

31623209 – Labtech Kft – CERTIFICATE – englisch – 2026-04-30 – MDR2017Q

FDA 510(k) Clearance 

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