Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009214950

FEI Number

3009214950

Entity Name

PLEXBIO CO. LTD.

City/State/Country

Taipei City, TW

Establishment Address

6F-1, No.351, Yangguang St., Neihu Dist., Taipei City 114, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PlexBio Co. Ltd. (Owner Number: 10080753)

Owner / Operator Contact Address

6F-1, No.351, Yangguang St., Neihu Dist., Taipei City, TW-TPE 114, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IntelliPrep Blood Genomic DNA Extraction Kit IntelliPrep FFPE DNA Extraction Kit IntelliPrep TRIO 240 Sample Preparation System IntelliPrep cfDNA Extraction Kit IntelliPrep Viral DNA/RNA Extraction Kit IntelliPrep FFPE RNA Extraction Kit IntelliPrep FFPE DNA Plus Extraction Kit IntelliPrep Blood total RNA Extraction 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	2021-11-18

Official Correspondent

Amber Chen

US Agent Details

Li Jiang Business: Hetai, Inc. Email: lee.jiang@hetai.co Phone: (415) 5315271

Related Public Records

Same Entity

PlexBio 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 3009214950. Last updated year: 2026. Please use registration number 3009214950 when referencing this establishment in official correspondence.