Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026885376

FEI Number

3026885376

Entity Name

Ganzhou Sanmei Industry and Trade Co., Ltd.

City/State/Country

ganzhou Jiangxi, CN

Establishment Address

4th Floor, Building 4, Jiurong Bathroom, South Zone, Economic Development Zone, Xingguo County, ganzhou Jiangxi 342400, CN

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Remanufacture Medical Device

Owner / Operator

Ganzhou Sanmei Industry And Trade Co., Ltd. (Owner Number: 10087506)

Owner / Operator Contact Address

4th Floor, Building 4, Jiurong Bathroom, South Zone, Economic Development Zone, Xingguo County, Ganzhou, CN-JX 342400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hot Cold Compress Gel Ice Packs Gel Ice Hat Hot Cold Compress Gel Ice Packs

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	2023-03-07
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2023-03-07

Official Correspondent

Lining Huang

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Ganzhou Sanmei Industry And Trade 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 3026885376. Last updated year: 2026. Please use registration number 3026885376 when referencing this establishment in official correspondence.