FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION

FDA Device Registration & Listing · Taipei, TW · Registration 3007699035

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007699035
FEI Number
3007699035
Entity Name
FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION
City/State/Country
Taipei, TW
Establishment Address
F5F, 105 Tung Hwa North Road,, Taipei 105, TW
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Formosa Biomedical Technology Corporation (Owner Number: 10029585)
Owner / Operator Contact Address
F5F, 105 Tung Hwa North Road,, Jiaoxi, TW-TPE 105, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K072170
PMA Number
N/A

All Registered Proprietary Names

DISPENSER, CEMENT MIXER, CEMENT, FOR CLINICAL USE WELLGRAFT PE I Resorbable Bone Void Filler A-GRIX Resorbable Bone Void Filler CALTRIX Resorbable Bone Void Filler A-GRIX TE Resorbable Bone Void Filler WELLGRAFT PE II Resorbable Bone Void Filler

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2010-05-10
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2010-05-10
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2009-06-02
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2014-07-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2014-07-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2014-07-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2009-06-02

Official Correspondent

Mina Han

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

Formosa Biomedical Technology Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007699035. Last updated year: 2026. Please use registration number 3007699035 when referencing this establishment in official correspondence.
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