Data / Medical devices / Media, Reproductive, Exempt
Media, Reproductive, Exempt (QKI): 9 FDA-registered makers in 7 countries
9 establishments in 7 countries are registered with the FDA to make Media, Reproductive, Exempt (product code QKI, Class 2, 21 CFR 884.6180). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QKI
- Device class
- 2
- Regulation
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| China | 2 |
| Germany | 2 |
| Canada | 1 |
| Belgium | 1 |
| Japan | 1 |
| Sweden | 1 |
| United States | 1 |
Makers of Media, Reproductive, Exempt
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arsci Biomedical Inc. | Jiaxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Casebioscience, Inc. | Guelph Ontario, Canada | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fertipro N.V. | BEERNEM West-Vlaanderen, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kitazato Corporation | Fuji Shizuoka, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen VitaVitro Biotech Co.,Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitrolife Sweden AB | Vastra Frolunda Vastra Gotaland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitromed GMBH | Jena Thuringia, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VITROMED GmbH | Langenfeld (Rheinland) North Rhine-Westphalia, Germany | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitrolife Inc. | Englewood, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.