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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Lepzi BTA Test — 1 UDI-DI variant, IVDD (Lepzi Diagnostika Ltd.)

MD Atlas
Lepzi Diagnostika Ltd.

Data from EUDAMED, last updated May 31, 2026

Lepzi BTA Test

B-03800502152088

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — General

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Manufacturer: Lepzi Diagnostika Ltd.

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Device characteristics

ReagentNear-patient testingProfessional testing

Clinical investigations

Investigation number: LD-BG006-CTR-001
Registered: No
Countries: China

Identity & classification

Basic UDI-DI: B-03800502152088
Device name: Lepzi BTA Test
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Version date: May 28, 2026

Manufacturer & authorised representative

Manufacturer

Name: Lepzi Diagnostika Ltd.
SRN: BG-MF-000051504
Country: Bulgaria
Email: office@lepzi.eu
Phone: +359897289089

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KSPN4ZWDK23YE8VNGEXGG1Y3

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Lepzi BTA Test03800502152088