Data / Medical devices / Poland / Medivena SP. Z O.O.

Medivena SP. Z O.O.: FDA-registered device maker in Warszawa Mazowieckie, Poland, 10 510(k) clearances

Name: Medivena SP. Z O.O. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medivena SP. Z O.O. is registered with the FDA (registration 3015485283) in Warszawa Mazowieckie, Poland. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 29, 2022. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Medivena SP. Z O.O.

FDA registration number: 3015485283
Address: Aleja Jana Pawla II 27, Warszawa Mazowieckie, Poland, 00-867
Owner or operator: MediVena Sp. z o.o. (10090324)
Roles: Exporter to the US, Foreign private label distributor
First device listed: March 12, 2024
Registered through: 2027
Brand names listed: GLUCO-CARE Pen Needles, GLUCO-CARE Safety Lancets, ONE-CARE GLIDE & LOCK Safety Blood Collection Wing Sets, ONE-CARE Insulin Syringes, ONE-CARE OPTI Safety Lancets, ONE-CARE PRO Safety Lancets, ONE-CARE PRO Safety Pen Needles, ONE-CARE Pen Needles and more

Devices it lists

Device	Product code	Class	Role	Source
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Exporter to the US, Foreign private label distributor	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 29, 2022	K222408	Disposable Safety Lancet	FMK	Substantially Equivalent	Beijing Ruicheng Medical Supplies Co., Ltd.	accessdata.fda.gov
November 17, 2022	K221178	Disposable Insulin Pen Needle	FMI	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
October 14, 2022	K213183	Safety Insulin Pen Needles	FMI	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov
October 3, 2022	K222376	Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)	FMK	Substantially Equivalent	Shandong Lianfa Medical Plastic Products Co. , Ltd.	accessdata.fda.gov
September 30, 2022	K222090	Safety Lancet	FMK	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
September 19, 2022	K221839	Lancet	FMK	Substantially Equivalent	Hebei Xinle Sci&Tech Co., Ltd.	accessdata.fda.gov
June 15, 2022	K220614	MEDOJECT fine Pen Needles	FMI	Substantially Equivalent	Chirana T. Injecta	accessdata.fda.gov
January 18, 2022	K201044	CHIRANA Insulin Syringes	FMF	Substantially Equivalent	Chirana T. Injecta	accessdata.fda.gov
June 4, 2018	K172763	Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder	JKA	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov
February 25, 2014	K133059	INSULIN PEN NEEDLE	FMI	Substantially Equivalent	Wenzhou Beipu Science & Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 29, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.