Data / Medical devices / Japan / Omura Kogyo Co., Ltd. Hara Factory
Omura Kogyo Co., Ltd. Hara Factory: FDA-registered device maker in Numazu Shizuoka, Japan, 1 510(k) clearance
Omura Kogyo Co., Ltd. Hara Factory is registered with the FDA (registration 3016927399) in Numazu Shizuoka, 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 3, 2026.
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- FDA registration number
- 3016927399
- Address
- 26-1 Hara, Numazu Shizuoka, Japan, 410-0312
- Owner or operator
- REPROLIFE Inc. (10073837)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 15, 2020
- Registered through
- 2026
- Brand names listed
- Tissue Storage: 10 Cryotec, Vitri Plate-10 Plates, Warm Plate-10 Plates
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction, Exempt | PUD | 2 | Contract manufacturer, 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.