Data / Medical devices / Slovakia / Unomedical S.R.O.

Unomedical S.R.O.: FDA-registered device maker in MICHALOVCE Kosicky, Slovakia, 3 510(k) clearances

Name: Unomedical S.R.O. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Unomedical S.R.O. is registered with the FDA (registration 3005778470) in MICHALOVCE Kosicky, Slovakia. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005778470
Address: Priemyselny Park 3, MICHALOVCE Kosicky, Slovakia, 07101
Owner or operator: ConvaTec (2241599)
Roles: Contract manufacturer, Manufacturer
First device listed: June 6, 2005
Registered through: 2026
Brand names listed: ACTIVE LIFE One-Piece Closed-End Pouch, ActiveLife CONVEX One-Piece Drainable Pouch with Durahesive, ActiveLife One-Piece Drainable Pouch with Durahesive, ActiveLife One-Piece Drainable Pouch with Durahesive Plus, ActiveLife One-Piece Drainable Pouch with Stomahesive, AutoLock SUR-FIT Drainable Pouch, COMBIHESIVE 2S, Drainage Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Bag, Urinary, Ileostomy	EXH	1	Manufacturer	accessdata.fda.gov
Catheter, Straight	EZD	2	Manufacturer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Contract manufacturer	accessdata.fda.gov
Pouch, Colostomy	EZQ	1	Manufacturer	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
January 25, 2024	K232665	GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)	EZD	Substantially Equivalent	Convatec	accessdata.fda.gov
June 22, 2022	K213283	GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter	GBM	Substantially Equivalent	Convatec Limited	accessdata.fda.gov
August 16, 2018	K181206	GentleCath Glide Intermittent Urinary Catheter	GBM	Substantially Equivalent	Convatec Limited	accessdata.fda.gov

Compare with other makers

Updated January 25, 2024. 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.