Data / Medical devices / Japan / Kofu Factory Of Terumo Corp.
Kofu Factory Of Terumo Corp.: FDA-registered device maker in NAKAKOMA-GUN Yamanashi, Japan, 5 510(k) clearances
Kofu Factory Of Terumo Corp. is registered with the FDA (registration 9681835) in NAKAKOMA-GUN Yamanashi, Japan. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 18, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9681835
- FEI number
- 3003752255
- Address
- 1727-1 Tsuijiarai, Showa-Cho, NAKAKOMA-GUN Yamanashi, Japan, 409-3853
- Owner or operator
- TERUMO CORP. (8010026)
- Roles
- Manufacturer
- First device listed
- August 21, 1996
- Registered through
- 2026
- Brand names listed
- Immucise Intradermal Injection System, Surflash I.V. Catheter, Surflash IV Catheter, Surflo Winged Infusion Set, TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER, TSCD Wafers, Terumo Sterile Tubing Welder (TSCD), Venoject Luer Adapter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Set, Transfer (Blood/Plasma) | KSB | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 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 |
|---|---|---|---|---|---|---|
| July 18, 2019 | K190427 | Immucise | FMF | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| February 26, 2010 | K100282 | TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER | FOZ | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| June 16, 1999 | K991406 | TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER | FOZ | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| November 30, 1998 | K983490 | TERUMO VENOJECT,LUER ADAPTER | JKA | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| July 14, 1977 | K771204 | SURFLO WINGED INFUSION SET | FPA | Substantially Equivalent | Terumo America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Transfer (Blood/Plasma)
- All makers of Set, Administration, Intravascular
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
Updated July 18, 2019. 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.