Data / Medical devices / Japan / Reprolife Inc.
Reprolife Inc.: FDA-registered device maker in Shinjuku-ku Tokyo, Japan, 1 510(k) clearance
Reprolife Inc. is registered with the FDA (registration 3013019894) in Shinjuku-ku Tokyo, Japan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 14, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013019894
- Address
- 2-5-3-9F Shinjuku, Shinjuku-ku Tokyo, Japan, 160-0022
- Owner or operator
- REPROLIFE Inc. (10054077)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 8, 2017
- Registered through
- 2026
- Brand names listed
- Cryotec (10 pieces) (Blue), Cryotec (10 pieces) (Green), Cryotec (10 pieces) (Red), Cryotec (10 pieces) (White), Cryotec (10 pieces) (Yellow), Cryotec (4 pieces) (Blue), Cryotec (4 pieces) (Green), Cryotec (4 pieces) (Red) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction, Exempt | PUD | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 14, 2016 | K162051 | Cryotec | MQK | Substantially Equivalent | Reprolife, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 14, 2016. 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.