Data / Medical devices / Japan / Seikagaku Corporation, Takahagi Plant
Seikagaku Corporation, Takahagi Plant: FDA-registered device maker in TAKAHAGI-SHI Ibaraki, Japan, 2 PMA approvals
Seikagaku Corporation, Takahagi Plant is registered with the FDA (registration 9612392) in TAKAHAGI-SHI Ibaraki, Japan. It lists 1 device type. The FDA files 2 PMA approvals under its listings, the newest dated March 22, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612392
- FEI number
- 1000255210
- Address
- 258-5, Aza-Matsukubo Oaza-Akahama, TAKAHAGI-SHI Ibaraki, Japan, 318-0001
- Owner or operator
- SEIKAGAKU CORPORATION (9043759)
- Roles
- Manufacturer
- First device listed
- December 17, 2007
- Registered through
- 2026
- Brand names listed
- Gel-One, SUPARTZ FX, VISCO-3
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Hyaluronic, Intraarticular | MOZ | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 22, 2011 | P080020 | GEL-ONE | MOZ | 54 | September 4, 2026 | accessdata.fda.gov |
| January 24, 2001 | P980044 | SUPARTZ FX | MOZ | 62 | September 4, 2026 | accessdata.fda.gov |
Compare with other makers
Updated September 4, 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.