Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016764493

FEI Number

3016764493

Entity Name

3D BIOMEDICINE SCIENCE & TECHNOLOGY CO., LIMITED

City/State/Country

Shanghai, CN

Establishment Address

Floor 1-4, No.1, Lane 396 Lvzhouhuan Street, Minhang District, Shanghai 201114, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

3D Biomedicine Science & Technology Co., Limited (Owner Number: 10063312)

Owner / Operator Contact Address

Floor 1-4, No.1, Lane 396 Lvzhouhuan Street, Minhang District, Shanghai, CN-SH 201114, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ReadiMag Pathogen Nucleic Acid Isolation Kit 32A Automated Viral DNA/RNA Isolation Kit ReadiMag FFPE DNA/RNA Kit ReadiMag gDNA Isolation Kit ReadiMag FFPE DNA Isolation Kit Automated Nucleic Acids Extraction System ANDiS 396 ANDiS Viral RNA Auto Extraction & Purification Kit 96A Automated Viral DNA/RNA Isolation Kit

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	2020-03-29

Official Correspondent

Ruiqiong Chen

US Agent Details

CAIFU CHEN Email: caifu.chen@3dmedcare.com Phone: (650) 6565993

Related Public Records

Same Entity

3D Biomedicine Science & Technology Co., Limited

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 3016764493. Last updated year: 2026. Please use registration number 3016764493 when referencing this establishment in official correspondence.