Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001576493

FEI Number

3001576493

Entity Name

P.T. SANKEI MEDICAL INDUSTRIES

City/State/Country

CIKANDE SERANG Banten, ID

Establishment Address

JL. MODERN INDUSTRI III KOMP.BPSP, A-12, KAWASAN INDUSTRI MODERN, CIKANDE SERANG Banten 42186, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sankei Co., LTD. (Owner Number: 8031654)

Owner / Operator Contact Address

1969-33, 34, Yawatakaigandori, Ichihara, Chiba, JP-NOTA 290-0067, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prep Sponge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2025-03-14
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2006-02-02

Official Correspondent

Yuki Yamane

US Agent Details

Amy Orrell Business: Mazza Healthcare, LLC Email: aorrell@mazzahealthcare.com Phone: (847) 2823444

Related Public Records

Same Entity

Sankei Co., LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001576493. Last updated year: 2026. Please use registration number 3001576493 when referencing this establishment in official correspondence.