Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010278338

FEI Number

3010278338

Entity Name

STIRILAB S.R.O.

City/State/Country

Ruzomberok Zilinsky, SK

Establishment Address

Textilna 23, Ruzomberok Zilinsky 03401, SK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STIRILAB s.r.o. (Owner Number: 10056161)

Owner / Operator Contact Address

Textilna 23, Ruzomberok, SK-ZI 03401, SK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2017-11-10
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2020-12-14

Official Correspondent

Vladimira Mydliarova

US Agent Details

Dennis Hoeft Business: Globe Scientific. Inc. Email: d.ackley@globescientific.com Phone: (201) 5991400

Related Public Records

Same Entity

STIRILAB s.r.o.

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-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010278338. Last updated year: 2026. Please use registration number 3010278338 when referencing this establishment in official correspondence.