FDA Registration Active 🇹🇼 Taiwan

MAXIGEN BIOTECH, INC.

Reg #: 3004146122 · FEI: 3004146122 · Expires 2026
Products
5
Proprietary Names
10
Establishment Types
2
Classifications
5

Registration Details

Registration Name
MAXIGEN BIOTECH, INC.
Registration Number
3004146122
FEI Number
3004146122
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No.88, Keji 1st Rd., Guishan District
City
Taoyuan City
Country
TW

Regulatory Submissions

510(k) Number
K242100

Owner / Operator

Firm Name
MAXIGEN BIOTECH, INC.
Operator Number
9103060
Address
No.88, Keji 1st Rd., --
City
Guishan District, Taoyuan City
State
TW-NOTA
Postal Code
33383
Country
TW

US Agent

Business Name
Qualtech Consulting LLC
Contact Name
Travis Hsu
Address
532 Arboles St
City
Monterey Park
State
CA
ZIP
91754
Country
US
Phone
626 3455899

Products

Device Name Product Code
Wound Dressing With Animal-Derived Material(S) KGN
Oral Wound Dressing OLR
Bone Grafting Material, Animal Source NPM
Filler, Bone Void, Calcium Compound MQV
Splint, Intranasal Septal LYA

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 MIMICLON collagen matrix

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)