Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002324535

FEI Number

3002324535

Entity Name

KOBAYASHI PHARMACEUTICAL CO., LTD.

City/State/Country

Chuo-ku Osaka, JP

Establishment Address

KDX Kobayashi Doshomachi Bldg, 4-10, Doshomachi 4-chome, Chuo-ku Osaka 541-0045, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

KOBAYASHI AMERICA MANUFACTURING, LLC (Owner Number: 10049550)

Owner / Operator Contact Address

245 KRAFT DRIVE, Dalton, GA 30721, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2016-10-13
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2019-09-04
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2015-06-17
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2017-11-03

Official Correspondent

No official correspondent registered.

US Agent Details

Poly Arimas Email: b.tipton@kobayashi.com Phone: (706) 2261800

Related Public Records

Same Entity

KOBAYASHI AMERICA MANUFACTURING, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002965034	HEFEI KOBAYASHI DAILY PRODUCTS CO., LTD.	HEFEI Anhui, CN
3031604327	Hefei Kobayashi Daily Products Co., LTD., Xiyou Road 4479 Facility	Hefei Anhui, CN
3003079019	KOBAYASHI AMERICA MANUFACTURING, LLC	Dalton, GA, US
3004201320	Kobayashi Pharmaceutical (China) Co.,Ltd.	Minhang District Shanghai, CN

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

Similar Registrations

Registration Number	Establishment Name	Location
3037007193	SHANGHAI HUIZHOU INDUSTRIAL CO., LTD	Shanghai City District, CN
3031182683	NINGBO YAMAI INDUSTRY AND TRADE CO., LTD.	Yuyao Zhejiang, CN
3016711531	BRANCH IN PHU THO, THYGESEN TEXTILE VIETNAM COMPANY LIMITED	Yen Lap Commune Phu Tho, VN
3008384548	ACTIVE-ICE, INC.	Norman, OK, US
3002393819	MEDICAL SPECIALTIES OF CALIFORNIA LIMITED	Orpington Kent, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002324535. Last updated year: 2026. Please use registration number 3002324535 when referencing this establishment in official correspondence.