Data / Medical devices / United States / Reprolife America, LLC
Reprolife America, LLC: FDA-registered device maker in Kingwood, TX, United States, 1 510(k) clearance
Reprolife America, LLC is registered with the FDA (registration 3018010054) in Kingwood, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 27, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3018010054
- Address
- 22751 Professional Dr Ste 220, Kingwood, TX, United States, 77339
- Owner or operator
- Experimental Culture Media Productions and Consignment, LLC (10092108)
- Roles
- Manufacturer
- First device listed
- December 5, 2024
- Registered through
- 2027
- Brand names listed
- Cryotec America, LLC, ECMPC, LLC, Reprolife America, LLC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Media, Reproductive | MQL | 2 | 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 |
|---|---|---|---|---|---|---|
| August 27, 2024 | K233846 | Vitrification Solution Set and Warming Solution Set | MQL | Substantially Equivalent | Ecmpc, LLC | accessdata.fda.gov |
Compare with other makers
Updated August 27, 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.