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Data / Medical devices / Japan / Asahi Kasei Medical Co., Ltd.

Asahi Kasei Medical Co., Ltd.: FDA-registered device maker in Chiyoda-ku Tokyo, Japan, 1 PMA approval

Asahi Kasei Medical Co., Ltd. is registered with the FDA (registration 3009960884) in Chiyoda-ku Tokyo, Japan. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated July 5, 1983. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3009960884
Address
1-1-2 Yurakucho, Chiyoda-ku Tokyo, Japan, 100-0006
Owner or operator
Asahi Kasei Medical Co., Ltd. (10040402)
Roles
Specification developer
First device listed
April 10, 2012
Registered through
2027
Brand names listed
Plasmaflo OP-05W(A)

Devices it lists

DeviceProduct codeClassRoleSource
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasmaMDP3Specification developeraccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
July 5, 1983P820033PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATORMDP16April 9, 2026accessdata.fda.gov

Compare with other makers

Updated April 9, 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.