KEISEI MEDICAL INDUSTRIAL CO., LTD.

FDA Device Registration & Listing · BUNKYO-KU Tokyo, JP · Registration 9611484

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
9611484
FEI Number
3002807390
Entity Name
KEISEI MEDICAL INDUSTRIAL CO., LTD.
City/State/Country
BUNKYO-KU Tokyo, JP
Establishment Address
19-6, HONGO SANCHOME, BUNKYO-KU Tokyo 113-0033, JP
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
KEISEI MEDICAL INDUSTRIAL CO., LTD. (Owner Number: 8031595)
Owner / Operator Contact Address
19-6, Hongo Sanchome, Bunkyo-ku, JP-13 113-0033, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Keisei Medical Keisei Medical Keisei Medical Keisei Medical

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2007-11-21
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2004-05-11
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2001-01-30
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2011-02-02

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwaartz Business: mdi Consultants, Inc.. Email: Alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

KEISEI MEDICAL INDUSTRIAL CO., LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K831798 I M, Inc. DISPOSABLE SCALPELS 1983-07-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2009 Surgical Specialties Corp 2
3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611484. Last updated year: 2026. Please use registration number 9611484 when referencing this establishment in official correspondence.
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