Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031604327

FEI Number

3031604327

Entity Name

Hefei Kobayashi Daily Products Co., LTD., Xiyou Road 4479 Facility

City/State/Country

Hefei Anhui, CN

Establishment Address

4479 Xiyou Road, High-Tech Zone, Hefei Anhui 230088, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

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
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 Business: KOBAYASHI AMERICA MANUFACTURING, LLC 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
3003079019	KOBAYASHI AMERICA MANUFACTURING, LLC	Dalton, GA, US
3002324535	KOBAYASHI PHARMACEUTICAL CO., LTD.	Chuo-ku Osaka, JP
3004201320	Kobayashi Pharmaceutical (China) Co.,Ltd.	Minhang District Shanghai, CN

Similar Registrations

Registration Number	Establishment Name	Location
3005051467	KOKUBO Co., Ltd	Kainan Wakayama, JP
3024623947	CRION CORP.	Seongnam-si Gyeonggi, KR
3042364161	Dizze, LLC	Salt Lake City, UT, US
3023339256	NINGBO RISENMED TECHNOLOGY CO.,LTD.	Ningbo Zhejiang, CN
3016816791	HUNAN JIANYUAN MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD	Loudi Hunan, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031604327. Last updated year: 2026. Please use registration number 3031604327 when referencing this establishment in official correspondence.