Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008742818

FEI Number

3008742818

Entity Name

PT. Hisamitsu Pharma Indonesia

City/State/Country

Sidoarjo Jawa Timur, ID

Establishment Address

Jl. H.R. Moch. Mangundiprojo, Desa/Kelurahan Banjarkemantren, Kec. Buduran, Kab., Sidoarjo Jawa Timur 61252, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hisamitsu Pharmaceutical Co., Inc. (Owner Number: 10094179)

Owner / Operator Contact Address

2-4-1, Marunouchi, Chiyoda-ku, JP-13 1006330, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ByeBye-FEVER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-12-26

Official Correspondent

Hirochika Takano

US Agent Details

Christina Miller Email: csmiller@biotechresearchgroup.com Phone: (813) 2985868

Related Public Records

Same Entity

Hisamitsu Pharmaceutical Co., Inc.

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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008742818. Last updated year: 2026. Please use registration number 3008742818 when referencing this establishment in official correspondence.