Data / Medical devices / Lithuania / Hollister Lietuva UAB
Hollister Lietuva UAB: FDA-registered device maker in Kaunas district, Lithuania, 5 510(k) clearances
Hollister Lietuva UAB is registered with the FDA (registration 3016675012) in Kaunas district, Lithuania. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016675012
- Address
- Oro parko str. 2, Sergeicikai village, Kaunas district, Lithuania, LT-54462
- Owner or operator
- Hollister Inc. (1480288)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 27, 2006
- Registered through
- 2026
- Brand names listed
- Adapt, Center Point Lock, CeraPlus, Compact, Conform 2, Dansac, DuoSoft, Fecal Collectors 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 |
| Collector, Ostomy | EXB | 1 | Manufacturer | accessdata.fda.gov |
| Protector, Ostomy | EXE | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| May 3, 2024 | K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) | EZD | Substantially Equivalent | Hollister Incorporated | accessdata.fda.gov |
| September 13, 2022 | K213575 | Female IC (Not Finalized) | EZD | Substantially Equivalent | Hollister Incorporated | accessdata.fda.gov |
| December 13, 2019 | K193148 | VaPro Plus Pocket, VaPro Plus | GBM | Substantially Equivalent | Hollister Incorporated | accessdata.fda.gov |
| December 18, 2018 | K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | GBM | Substantially Equivalent | Hollister Incorporated | accessdata.fda.gov |
| June 22, 2018 | K180824 | VaPro 2 Intermittent Catheter | GBM | Substantially Equivalent | Hollister Incorporated | accessdata.fda.gov |
Compare with other makers
- All makers of Collector, Ostomy
- All makers of Catheter, Urethral
- All makers of Protector, Ostomy
- All makers of Catheter, Straight
Updated May 3, 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.