Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015485283

FEI Number

3015485283

Entity Name

MEDIVENA SP. Z O.O.

City/State/Country

Warszawa Mazowieckie, PL

Establishment Address

Aleja Jana Pawla II 27, Warszawa Mazowieckie 00-867, PL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MediVena Sp. z o.o. (Owner Number: 10090324)

Owner / Operator Contact Address

Aleja Jana Pawla II 27, Warszawa, PL-14 00-867, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213183

PMA Number

N/A

All Registered Proprietary Names

GLUCO-CARE Pen Needles GLUCO-CARE Safety Lancets ONE-CARE Pen Needles ONE-CARE GLIDE & LOCK Safety Blood Collection Wing Sets ONE-CARE PRO Safety Lancets ONE-CARE PRO Safety Pen Needles

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	2025-03-10
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-03-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-01-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-03-10
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2024-03-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-03-12

Official Correspondent

No official correspondent registered.

US Agent Details

Jaroslaw Moleda Business: MediVena Email: jarek.moleda@medivena.com Phone: (404) 4221513

Related Public Records

Same Entity

MediVena Sp. z o.o.

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
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

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-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
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.

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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 3015485283. Last updated year: 2026. Please use registration number 3015485283 when referencing this establishment in official correspondence.