Asahi Kasei Medical MT Corp. Oita Works

FDA Device Registration & Listing · OITA-SHI, JP · Registration 8010002

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8010002
FEI Number
3002806407
Entity Name
Asahi Kasei Medical MT Corp. Oita Works
City/State/Country
OITA-SHI, JP
Establishment Address
2111-2 OAZA SATO, OITA-SHI 870-0396, JP
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Liposorber LA-15 system Liposorber LA-15 system Liposorber LA-15 system Plasmaflo OP-05W(A)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PBN Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients Unknown Class f N/A 2013-11-19
PBN Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients Unknown Class f N/A 2018-06-21
MMY Lipoprotein, Low Density, Removal Unknown Class 3 N/A 2013-01-30
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
3009960884 ASAHI KASEI MEDICAL CO., LTD. Chiyoda-ku Tokyo, JP

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3009960884 ASAHI KASEI MEDICAL CO., LTD. Chiyoda-ku Tokyo, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010002. Last updated year: 2026. Please use registration number 8010002 when referencing this establishment in official correspondence.
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