Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021043070

FEI Number

3021043070

Entity Name

HANGZHOU DANWEI BIOTECHNOLOGY CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No.2959, Yuhangtang Road, Cangqian Sub-District, Yuhang District, Hangzhou Zhejiang 311100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Danwei Biotechnology Co., Ltd (Owner Number: 10083125)

Owner / Operator Contact Address

No.2959, Yuhangtang Road, Cangqian Sub-District, Yuhang District, Hangzhou, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Viral Nucleic Acid Extraction Kit Viral Nucleic Acid Extraction Kit (Magnetic Beads)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2021-10-26

Official Correspondent

Joyce Pang

US Agent Details

Bryan Fang Email: Rocio.perez@healgen.com Phone: (713) 7338088

Related Public Records

Same Entity

Hangzhou Danwei Biotechnology 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 3021043070. Last updated year: 2026. Please use registration number 3021043070 when referencing this establishment in official correspondence.