Data / Medical devices / Hungary / Coloplast Hungary KFT
Coloplast Hungary KFT: FDA-registered device maker in TATABANYA Komarom-Esztergom, Hungary, 9 510(k) clearances
Coloplast Hungary KFT is registered with the FDA (registration 3003814961) in TATABANYA Komarom-Esztergom, Hungary. It lists 13 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 10, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003814961
- Address
- Buzavirag Ut 15, TATABANYA Komarom-Esztergom, 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 Irrigation Pressplate, Assura Irrigation Set, Assura Kit, Assura Night bag, Assura Ostomy Pouch, Assura Urostomy Pouch and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Drainage, With Adhesive, Ostomy | FON | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Continuous Irrigation | GBQ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Nephrostomy | LJE | U | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Retention Type, Balloon | EZL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Ureteral, Gastro-Urology | EYB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Collector, Ostomy | EXB | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Catheter, Ureteral | EZN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Ostomy | EXD | 2 | Manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Manufacturer | accessdata.fda.gov |
| Stent, Ureteral | FAD | 2 | 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 |
|---|---|---|---|---|---|---|
| March 10, 2022 | K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | LJE | Unknown | Coloplast Corp. | accessdata.fda.gov |
| February 25, 2021 | K201436 | Vortek Single Loop Ureteral Stent | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| October 4, 2018 | K182122 | Ureteric Catheters | EYB | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| December 21, 2017 | K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters | EYB | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| August 17, 2017 | K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | EZN | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| July 16, 2012 | K121833 | OSTOMY IRRIGATION SET | EXD | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| April 23, 2009 | K090217 | BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 | FBK | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| January 4, 2002 | K013174 | PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, | EZL | Substantially Equivalent | Porges S.A. | accessdata.fda.gov |
| December 20, 2001 | K013172 | PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL | EZL | Substantially Equivalent | Porges S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Ureteral, Gastro-Urology
- All makers of Catheter, Retention Type, Balloon
- All makers of Catheter, Continuous Irrigation
- All makers of Lavage, Jet
- All makers of Bag, Urine Collection, Leg, For External Use, Sterile
- All makers of Bag, Urine Collection, Leg, For External Use, Non-Sterile
Updated March 10, 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.