Data / Medical devices / Netherlands / Hollister Services BV
Hollister Services BV: FDA-registered device maker in Roosendaal Noord-Brabant, Netherlands, 11 510(k) clearances
Hollister Services BV is registered with the FDA (registration 3014404707) in Roosendaal Noord-Brabant, Netherlands. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated May 18, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014404707
- Address
- Boekerrman 2 XK Oud Gastel, Roosendaal Noord-Brabant, Netherlands, 4751
- Owner or operator
- Hollister Inc. (1480288)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- September 27, 2006
- Registered through
- 2026
- Brand names listed
- Adapt, Advance (KOD), Advance Plus (KOD), Advance Plus Pocket (KOD), CeraPlus, Dansac, HolliHesive, Hollister 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 |
| Catheter, Urological | KOD | 2 | Exporter to the US | accessdata.fda.gov |
| Protector, Ostomy | EXE | 1 | Exporter to the US | accessdata.fda.gov |
| Solvent, Adhesive Tape | KOX | 1 | Exporter to the US | accessdata.fda.gov |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | 2 | Exporter to the US | 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 18, 2026 | K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | EZD | Substantially Equivalent | Hollister Incorporated | accessdata.fda.gov |
| 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 |
| January 27, 2022 | K211436 | Intermittent Catheter (Not Finalized) | GBM | 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 |
| September 9, 2015 | K152268 | VAPRO PLUS POCKET Intermittent Catheter | GBM | Substantially Equivalent | Hollister Incorporated | accessdata.fda.gov |
| January 9, 2015 | K143594 | VaPro Pocket | GBM | Substantially Equivalent | Hollister Incorporated | accessdata.fda.gov |
| August 22, 2014 | K141642 | VAPRO INTERMITTENT CATHETER | GBM | Substantially Equivalent | Hollister Incorporated | accessdata.fda.gov |
| January 14, 2002 | K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | KOD | Substantially Equivalent | Hollister, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Urological
- All makers of Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- All makers of Catheter, Urethral
- All makers of Solvent, Adhesive Tape
- All makers of Protector, Ostomy
- All makers of Catheter, Straight
Updated May 18, 2026. 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.