Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006532105

FEI Number

3006532105

Entity Name

PHARMIGENE, INC.

City/State/Country

Xinzhuang Dist. New Taipei, TW

Establishment Address

7F., No. 302, Jianguo 1st Rd.,, Xinzhuang Dist. New Taipei 242047, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Pharmigene, Inc. (Owner Number: 9101067)

Owner / Operator Contact Address

4F, No.17, Ln. 171, Sec. 2, Jiuzong Rd.,, Neihu Dist., TW-TPE 11494, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PG0430 Detection Reagent PG1075 Detection Reagent PG27 Detection reagent PG1502 Detection Reagent PG1639 Detection Reagent PG3101 Detection Reagent PG5801 Detection Reagent PG5701 Detection Reagent PGIC01 Detection Reagent PG5101 Detection Reagent PG3901 Detection Reagent PG0602 Detection Reagent PG0636 Detection Reagent PG0681 Detection Reagent PG1301 Detection Reagent PG3802 Detection Reagent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2007-05-01

Official Correspondent

No official correspondent registered.

US Agent Details

Steven Wu Business: Pharmigene, Inc. Email: steven.wu@tswcore.com Phone: (510) 3770795

Related Public Records

Same Entity

Pharmigene, Inc.

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 3006532105. Last updated year: 2026. Please use registration number 3006532105 when referencing this establishment in official correspondence.