Data / Medical devices / Netherlands / Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre
Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre: FDA-registered device maker in SCHIPOL RIJK Noord-Holland, Netherlands, 9 510(k) clearances and 2 PMA approvals
Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre is registered with the FDA (registration 3003365815) in SCHIPOL RIJK Noord-Holland, Netherlands. It lists 14 device types. The FDA files 9 510(k) clearances and 2 PMA approvals under its listings, the newest dated October 4, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003365815
- Address
- Koolhovenlaan 110, SCHIPOL RIJK Noord-Holland, Netherlands, 1119 NH
- Owner or operator
- Bausch & Lomb Incorporated (9913003)
- Roles
- Exporter to the US
- First device listed
- January 1, 1993
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Exporter to the US | accessdata.fda.gov |
| Eye Tray | OJK | 2 | Exporter to the US | accessdata.fda.gov |
| Fluid, Intraocular | LWL | 3 | Exporter to the US | accessdata.fda.gov |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Exporter to the US | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Exporter to the US | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Exporter to the US | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US | accessdata.fda.gov |
| Lens, Guide, Intraocular | KYB | 1 | Exporter to the US | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Exporter to the US | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Exporter to the US | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Exporter to the US | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Exporter to the US | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Exporter to the US | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 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 |
|---|---|---|---|---|---|---|
| October 4, 2019 | K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | MSS | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| February 13, 2015 | K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| September 28, 2012 | K113852 | BAUSCH & LOMB IOL INJECTOR | MSS | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| June 5, 2012 | K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| June 10, 2008 | K080755 | SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | MVN | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| March 12, 2008 | K073023 | STERILS SINGLE-USE I/A HANDPIECES | HQC | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| November 1, 2007 | K070669 | IOL INJECTOR SET | KYB | Substantially Equivalent | Medicel AG | accessdata.fda.gov |
| June 22, 2006 | K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | MVN | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| August 17, 1988 | K882802 | STORZ DISPOSABLE BIPOLAR PENCILS | GXI | Substantially Equivalent | Storz Instrument Co. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 16, 1996 | P960022 | SOFLENS66(TM) | LPM | 13 | April 8, 2025 | accessdata.fda.gov |
| November 4, 1994 | P910071 | ADATOMED SILICONE OIL OP5000 | LWL | 17 | December 22, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Phacofragmentation
- All makers of Cannula, Ophthalmic
- All makers of Spatula, Ophthalmic
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
- All makers of Fluid, Intraocular
Updated April 8, 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.