Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022121584

FEI Number

3022121584

Entity Name

ZHEJIANG HELI REFRIGERATION EQUIPMENT CO., LTD.

City/State/Country

Jinhua Zhejiang, CN

Establishment Address

#3 Nanqiao North Road, Lanjiang Street, Lanxi, Jinhua Zhejiang 321100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZHEJIANG HELI REFRIGERATION EQUIPMENT CO., LTD. (Owner Number: 10095002)

Owner / Operator Contact Address

#3 Nanqiao North Road, Lanjiang Street, Lanxi, Jinhua, CN-ZJ 321100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BLOOD STORAGE FREEZER REFRIGERATOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2026-01-14

Official Correspondent

Jianjun Chen

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

ZHEJIANG HELI REFRIGERATION EQUIPMENT CO., LTD.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022121584. Last updated year: 2026. Please use registration number 3022121584 when referencing this establishment in official correspondence.