Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016579901

FEI Number

3016579901

Entity Name

SUNPHORIA CO., LTD.

City/State/Country

Taipei City, TW

Establishment Address

12F-1, No.51, Hengyang Rd.,, Zhongzheng Dist.,, Taipei City 10045, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Sunphoria Co., Ltd. (Owner Number: 10062637)

Owner / Operator Contact Address

12F-1, No.51, Hengyang Rd.,, Zhongzheng Dist.,, Taipei City, TW-TPE 10045, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK231018

PMA Number

N/A

All Registered Proprietary Names

AHC Platelet Concentrate Separator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2025-12-04

Official Correspondent

Ying-Che Chang

US Agent Details

Jeffrey Dahlen Business: Hikari Dx, Inc. Email: jeff@hikaridx.com Phone: (619) 7420203

Related Public Records

Same Entity

Sunphoria 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 3016579901. Last updated year: 2026. Please use registration number 3016579901 when referencing this establishment in official correspondence.