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
- [email protected]
- Phone
- 626 3455899
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2025-11-26 |
| Oral Wound Dressing | OLR | Class U | Unknown | No | 2024-01-01 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2016-04-25 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2018-05-24 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2024-01-10 |
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)