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Clinico Medical Sp. z o.o.: FDA-registered device maker in Blonie/Miekinia Dolnoslaskie, Poland, 8 510(k) clearances

Name: Clinico Medical Sp. z o.o. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Clinico Medical Sp. z o.o. is registered with the FDA (registration 3008810357) in Blonie/Miekinia Dolnoslaskie, Poland. It lists 15 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 16, 2023. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3008810357
Address: Blonie k/ Wroclawia, ul. Roberta Kocha 1, Blonie/Miekinia Dolnoslaskie, Poland, 55-330
Owner or operator: Fresenius Kabi AG (9027285)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: November 16, 2007
Registered through: 2027
Brand names listed: ASTOTUBE, AbbVie J, AbbVie PEG, Accu-Chek Rapid-D, Accu-Chek Spirit 3.15 ml Cartridge system, CATSmart, CATSmart System, COMPOGUARD and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Autotransfusion	CAC	2	Manufacturer	accessdata.fda.gov
Calculator, Drug Dose	NDC	2	Contract manufacturer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Manufacturer	accessdata.fda.gov
Device, Blood Mixing And Blood Weighing	KSQ	1	Manufacturer	accessdata.fda.gov
Hematocrit, Tube, Rack, Sealer, Holder	GHY	2	Manufacturer	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Pump, Infusion	FRN	2	Manufacturer	accessdata.fda.gov
Pump, Infusion, Insulin	LZG	2	Contract manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Manufacturer	accessdata.fda.gov
Supplies, Blood-Bank	KSS	1	Manufacturer	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Contract manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Warmer, Blood, Non-Electromagnetic Radiation	BSB	2	Contract manufacturer, Contract sterilizer	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
June 16, 2023	K221121	Volumat Polyethylene I.V. Administration Set	FPA	Substantially Equivalent	Fresenius Kabi	accessdata.fda.gov
June 2, 2023	K220301	Volumat Line	FPA	Substantially Equivalent	Fresenius Kabi	accessdata.fda.gov
June 1, 2022	K212445	freeflex+ Transfer Adapter	LHI	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov
September 27, 2019	K192368	CATSmart	CAC	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov
December 10, 2018	K180831	CATSmart	CAC	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov
June 15, 2017	K162826	Encore Neutral	FPA	Substantially Equivalent	Rymed Technologies, LLC	accessdata.fda.gov
September 16, 2016	K160735	CATSmart	CAC	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov
May 1, 2013	K121613	AGILIA INFUSION SYSTEM	FRN	Substantially Equivalent	Fresenius Kabi AG	accessdata.fda.gov

Compare with other makers

Updated June 16, 2023. 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.