Data / Medical devices / Netherlands / Viroclinics Biosciences B.V.
Viroclinics Biosciences B.V.: FDA-registered device maker in Rotterdam Zuid-Holland, Netherlands, 3 510(k) clearances
Viroclinics Biosciences B.V. is registered with the FDA (registration 3010600155) in Rotterdam Zuid-Holland, Netherlands. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 7, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010600155
- Address
- Marconistraat 16, Rotterdam Zuid-Holland, Netherlands, 3029 AK
- Owner or operator
- NJK & Associates (10045793)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- December 30, 2013
- Registered through
- 2026
- Brand names listed
- FLOOSwabs, Hygiene Mask - 2PLY-WHITE-EARLOOPS, Micro Touch Latex Exam Gloves, UTM Tubes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | 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 |
|---|---|---|---|---|---|---|
| December 7, 2004 | K042970 | COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM | JSM | Substantially Equivalent | Copan Diagnostics, Inc. | accessdata.fda.gov |
| December 6, 2004 | K042817 | MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) | LZA | Substantially Equivalent | Ansell Healthcare Products, Inc. | accessdata.fda.gov |
| November 13, 2002 | K023153 | MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL | LYY | Substantially Equivalent | Ansell Healthcare Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Surgical Apparel
- All makers of Micro Pipette
- All makers of Culture Media, Non-Propagating Transport
- All makers of Polymer Patient Examination Glove
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Applicator, Absorbent Tipped, Sterile
Updated December 7, 2004. 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.