Data / Medical devices / Hungary / Coloplast Hungary KFT
Coloplast Hungary KFT: FDA-registered device maker in NYIRBATOR Szabolcs-Szatmar-Bereg, Hungary, 15 510(k) clearances
Coloplast Hungary KFT is registered with the FDA (registration 3006606901) in NYIRBATOR Szabolcs-Szatmar-Bereg, Hungary. It lists 9 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 27, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006606901
- Address
- Coloplast Utca 2, NYIRBATOR Szabolcs-Szatmar-Bereg, Hungary, 4300
- Owner or operator
- Coloplast Corp. (8010144)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 20, 2000
- Registered through
- 2027
- Brand names listed
- Aveeno Skin Relief No-Scratch Barrier Patch, BAND-AID Hydroseal Acne Blemish Patch, Band-Aid, Benadryl, Biatain Adhesive, Biatain Ag Non-Adhesive, Biatain Non-Adhesive, Biatain Silicone and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Straight | EZD | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Urethral | GBM | 2 | Manufacturer | accessdata.fda.gov |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Enema Kit | FCE | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer | accessdata.fda.gov |
| Rod, Colostomy | EZP | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| June 27, 2025 | K251116 | Luja Coudé | EZD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| April 17, 2025 | K250270 | Luja Set | EZD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| November 26, 2024 | K242049 | SureCath Set | EZD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| July 26, 2024 | K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | EZD | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| December 2, 2022 | K221401 | Self-Cath and Self-Cath Plus | EZD | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| September 21, 2022 | K222059 | SpeediCath Flex Set | EZD | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| April 26, 2022 | K210250 | SpeedCath Compact Male | EZD | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| March 8, 2022 | K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) | EZD | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| November 13, 2020 | K200820 | SpeediCath Compact Set | GBM | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| November 2, 2020 | K192904 | SpeediCath Compact Set | GBM | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| July 30, 2020 | K200142 | SpeediCath Soft | GBM | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| February 21, 2020 | K191536 | Biatain Silicone Ag | FRO | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| October 25, 2018 | K180258 | SpeediCath Standard | GBM | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| September 3, 2015 | K140310 | Peristeen Anal Irrigation System | KNT | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| February 17, 2010 | K100218 | BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | FRO | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Straight
- All makers of Catheter, Urethral
- All makers of Rod, Colostomy
- All makers of Dressing, Wound, Drug
- All makers of Enema Kit
- All makers of Tubes, Gastrointestinal (And Accessories)
Updated June 27, 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.