Statistics for Lepzi Diagnostika Ltd.

4Total Devices

4Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for Lepzi Diagnostika Ltd.

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for Lepzi Diagnostika Ltd.

Showing 1–4 of 4 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Lepzi BNP Test	`LD_BG001`	`03800502152002`	1	On the market
Lepzi BTA Test	`LD_BG006`	`03800502152088`	1	On the market
Lepzi cTnI Test	`LD_BG003`	`03800502152026`	1	On the market
Lepzi PLGF Test	`LD_BG002`	`03800502152019`	1	On the market

Device families (Basic UDI-DI) of Lepzi Diagnostika Ltd.

Showing 1–1 of 1 device families.

Lepzi PLGF TestB-03800502152019

Market presence of Lepzi Diagnostika Ltd.

Devices placed in 1 country

Bulgaria4

MD Atlas update: May 30, 2026

Lepzi Diagnostika Ltd.

BG-MF-000051504

Active

Address: Professor Hristo Vakarelski , 19 1700 Sofia
Role: Manufacturer
Date of registration: Jan 14, 2026
Country: BG Bulgaria

About Lepzi Diagnostika Ltd.

SRN: BG-MF-000051504
Role: Manufacturer
Country: Bulgaria
Organization name: Lepzi Diagnostika Ltd.
EU VAT number: BG206039179
EORI: BGA206039179ZZZZ9
Trade register: 206039179
Date of registration: Jan 14, 2026

Contact details for Lepzi Diagnostika Ltd.

Address: 19, PROFESSOR HRISTO VAKARELSKI 1700 SOFIA BULGARIA
Phone: +359897289089
Email: office@lepzi.eu
Website: https://www.lepzi.com/

Validator

Name: Bulgarian Drug Agency Department "Market Supervision and lnspections" Division "Medical Devices"
SRN: BG-CA-031
Phone: +359 2 8903555
Email: bda@bda.bg

Officers and regulatory representatives of Lepzi Diagnostika Ltd.

GEORGIEVA Iliyana
Person Responsible for Regulatory Compliance (PRRC) under Regulation (EU) 2017/746 (IVDR). Responsible for ensuring device conformity prior to release; that technical documentation and EU declarations of conformity are drawn up and kept up to date; that post-market surveillance and vigilance obligations are fulfilled; that serious incidents and field safety corrective actions are reported in accordance with IVDR; and that the Quality Management System is properly implemented and maintained.
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