Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005146144

FEI Number

3005146144

Entity Name

UAB KITRON

City/State/Country

KAUNAS Kauno Apskritis, LT

Establishment Address

TAIKOS PR. 151, KAUNAS Kauno Apskritis LT-52119, LT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

UAB KITRON (Owner Number: 9072718)

Owner / Operator Contact Address

TAIKOS PR. 151, --, KAUNAS, LT-NOTA LT-52119, LT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hemocue WBC System HemoCue Hb 301 System HemoCue Hb 301 System HemoCue Hb 801 System V-VAC MANUAL SUCTION UNIT HemoCue Plasma/Low System HemoCue Hb 301 System HemoCue Hb 201 DM System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2018-04-27
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2021-02-10
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2018-04-27
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2019-02-05
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2005-05-03
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2018-04-27
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2018-04-27
GKR	System, Hemoglobin, Automated	Hematology	Class 2	864.5620	2018-04-27

Official Correspondent

VYTIS VARNAVICIUS

US Agent Details

Danny West Business: FDA Agent Pro LLC Email: dwest@fdaagentpro.com Phone: (619) 4103883

Related Public Records

Same Entity

UAB KITRON

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005146144. Last updated year: 2026. Please use registration number 3005146144 when referencing this establishment in official correspondence.