Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004201320

FEI Number

3004201320

Entity Name

Kobayashi Pharmaceutical (China) Co.,Ltd.

City/State/Country

Minhang District Shanghai, CN

Establishment Address

Blg.2-507A, 508 Chundong Road, Minhang District Shanghai 201108, CN

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
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2015-06-17
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2018-04-26
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-10-13

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
3002324535	KOBAYASHI PHARMACEUTICAL CO., LTD.	Chuo-ku Osaka, JP

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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3017103360	RAIN EYE DROPS LLC	Wilmington, DE, US
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004201320. Last updated year: 2026. Please use registration number 3004201320 when referencing this establishment in official correspondence.