Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008272066

FEI Number

3008272066

Entity Name

CHIRANA T.INJECTA, A.S.

City/State/Country

Stara Tura Trenciansky, SK

Establishment Address

Nam. Dr. A.Schweitzera 194, Stara Tura Trenciansky 916 01, SK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CHIRANA T.Injecta, a.s. (Owner Number: 10046566)

Owner / Operator Contact Address

Nam. Dr. A.Schweitzera 194, Stara Tura, SK-TC 916 01, SK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201044

PMA Number

N/A

All Registered Proprietary Names

Blood Collection Needles MEDOJECT fine Pen Needles Insulin Syringe ONE-CARE Insulin syringes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-10-25
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-10-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-10-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-10-25

Official Correspondent

Rastislav Broska

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 2545756

Related Public Records

Same Entity

CHIRANA T.Injecta, a.s.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

Similar Registrations

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3006850123	JAPAN IRRADIATION SERVICE CO., LTD	Naka-gun Ibaraki, JP
3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008272066. Last updated year: 2026. Please use registration number 3008272066 when referencing this establishment in official correspondence.