Kofu Factory of Terumo Corp.
Country not established FDA
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Kofu Factory of Terumo Corp. makes
The company manufactures insulin delivery needles, including micro-tapered pen needles and pen injector needles designed for diabetes management, as well as safety intravenous catheters for peripheral vein access.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The manufacturer operates from the United States.
Catalogue
Terumo Micro Tapered Pen Needle Ref K052561
Regimes: 510(k) Registry: 510(k)Terumo Pen Injector Needle 34 Ref K140516
Regimes: 510(k) Registry: 510(k)Surfflash(R) Plus Safety I.V. Catheter Ref K123267
Regimes: 510(k) Registry: 510(k)Surflash Safety I.V. Catheter Ref K141138
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Kofu Factory Of Terumo Corp. NAKAKOMA-GUN Yamanashi · JP FEI 3003752255
Frequently asked questions
How many devices does Kofu Factory of Terumo Corp. have in the registry?
The registry currently lists 4 devices for Kofu Factory of Terumo Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kofu Factory of Terumo Corp.'s devices?
Among its 4 most recently registered devices, Kofu Factory of Terumo Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Kofu Factory of Terumo Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Kofu Factory of Terumo Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kofu Factory of Terumo Corp. in the registry?
The most recently registered devices listed for Kofu Factory of Terumo Corp. include TERUMO MICRO TAPERED PEN NEEDLE, Terumo Pen Injector Needle 34, SURFFLASH(R) PLUS SAFETY I.V. CATHETER and SURFLASH SAFETY I.V. CATHETER.
Which FDA establishments are linked to Kofu Factory of Terumo Corp.?
1 FDA establishment is linked to Kofu Factory of Terumo Corp. in the registry; they are listed on the company page.