Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015169752

FEI Number

3015169752

Entity Name

PURIBLOOD MEDICAL CO., LTD.

City/State/Country

Hsinchu, TW

Establishment Address

2F, No.11, Gongye E. 9th Rd., Baoshan Township,, Hsinchu 30075, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

PURIBLOOD MEDICAL CO., LTD. (Owner Number: 10060198)

Owner / Operator Contact Address

2F, No.11, Gongye E. 9th Rd., Baoshan Township,, Hsinchu, TW-HSQ 30075, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK180188

PMA Number

N/A

All Registered Proprietary Names

Puriblood Leukocyte Reduction Filtration System for Red Blood Cells

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2019-04-10

Official Correspondent

Edward Chang

US Agent Details

David McCool Business: Maveric Medical LLC Email: customerservice@mavericmedical.com Phone: (951) 3193353

Related Public Records

Same Entity

PURIBLOOD MEDICAL 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 3015169752. Last updated year: 2026. Please use registration number 3015169752 when referencing this establishment in official correspondence.