Data / Medical devices / Hungary / Coloplast Hungary, KFT

Coloplast Hungary, KFT: FDA-registered device maker in Tatabanya, Hungary, 1 510(k) clearance

Name: Coloplast Hungary, KFT FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Coloplast Hungary, KFT is registered with the FDA (registration 3008262278) in Tatabanya, Hungary. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2025. 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 Coloplast Hungary, KFT

FDA registration number: 3008262278
Address: Kerek utca 3, Tatabanya, Hungary, 2800
Owner or operator: Coloplast Corp. (8010144)
Roles: Manufacturer, Repackager or relabeler
First device listed: November 2, 1995
Registered through: 2027
Brand names listed: Assura 1pc Kit, Assura CV Kit, Assura Kit, Assura Night bag, Assura Ostomy Pouch, Assura Urostomy Pouch, Assura Urostomy bag, Aveeno Skin Relief No-Scratch Barrier Patch and more

Devices it lists

Device	Product code	Class	Role	Source
Bag, Drainage, With Adhesive, Ostomy	FON	1	Repackager or relabeler	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-Sterile	NNW	1	Repackager or relabeler	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Liquid, Skin Protectant	NEC	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Straight	EZD	2	Manufacturer	accessdata.fda.gov
Collector, Ostomy	EXB	1	Repackager or relabeler	accessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-Sterile	NNX	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
Ostomy Care Kit	PQE	1	Repackager or relabeler	accessdata.fda.gov
Rod, Colostomy	EZP	2	Repackager or relabeler	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	Repackager or relabeler	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Repackager or relabeler	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
April 17, 2025	K250270	Luja Set	EZD	Substantially Equivalent	Coloplast Corp.	accessdata.fda.gov

Compare with other makers

Updated April 17, 2025. 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.