Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009960884

FEI Number

3009960884

Entity Name

ASAHI KASEI MEDICAL CO., LTD.

City/State/Country

Chiyoda-ku Tokyo, JP

Establishment Address

1-1-2 Yurakucho, Chiyoda-ku Tokyo 100-0006, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Asahi Kasei Medical Co., Ltd. (Owner Number: 10040402)

Owner / Operator Contact Address

1-1-2 Yurakucho, Chiyoda-ku, JP-13 100-0006, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P820033

All Registered Proprietary Names

Plasmaflo OP-05W(A)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDP	Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma	Unknown	Class 3	N/A	2012-04-10

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Asahi Kasei Medical Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8010002	Asahi Kasei Medical MT Corp. Oita Works	OITA-SHI, JP

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009960884. Last updated year: 2026. Please use registration number 3009960884 when referencing this establishment in official correspondence.