Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004146122

FEI Number

3004146122

Entity Name

MAXIGEN BIOTECH, INC.

City/State/Country

Taoyuan City, TW

Establishment Address

No.88, Keji 1st Rd., Guishan District, Taoyuan City 33383, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAXIGEN BIOTECH, INC. (Owner Number: 9103060)

Owner / Operator Contact Address

No.88, Keji 1st Rd., --, Guishan District, Taoyuan City, TW-NOTA 33383, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223126

PMA Number

N/A

All Registered Proprietary Names

HealiAid Collagen Wound Dressing SurgiAid Collagen Wound Dressing HealiAid Dental Collagen Wound Dressing Curagen Collagen Wound Dressing VeraFill Dental Collagen Wound Dressing bone grafting material, animal source filler, bone void, calcium compound - AttraX Scaffold 10cc Morsels (5015110); AttraX Scaffold 20cc Morsels (5015120); At NasoAid Intranasal Splint filler, bone void, calcium compound - FORMAGRAFT HealiAid Collagen Wound Dressing MIMICLON collagen matrix SurgiAid Collagen Wound Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-11-26
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2024-01-01
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2016-04-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-05-24
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2024-01-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-06-18
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-01-01

Official Correspondent

No official correspondent registered.

US Agent Details

Travis Hsu Business: Qualtech Consulting LLC Email: travis@qualtechs.com Phone: (626) 3455899

Related Public Records

Same Entity

MAXIGEN BIOTECH, INC.

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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
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

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3031600472	TIGER WOUND CARE MEDICAL, LLC	Conshohocken, PA, US
3009882464	Synergy Health AST, LLC	Saxonburg, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004146122. Last updated year: 2026. Please use registration number 3004146122 when referencing this establishment in official correspondence.