Data / Medical devices / Taiwan / Maxigen Biotech, Inc.
Maxigen Biotech, Inc.: FDA-registered device maker in Taoyuan City, Taiwan, 4 510(k) clearances
Maxigen Biotech, Inc. is registered with the FDA (registration 3004146122) in Taoyuan City, Taiwan. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004146122
- Address
- No.88, Keji 1st Rd., Guishan District, Taoyuan City, Taiwan, 33383
- Owner or operator
- MAXIGEN BIOTECH, INC. (9103060)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 18, 2007
- Registered through
- 2026
- Brand names listed
- Curagen Collagen Wound Dressing, HealiAid Collagen Wound Dressing, HealiAid Dental Collagen Wound Dressing, MIMICLON collagen matrix, NasoAid Intranasal Splint, SurgiAid Collagen Wound Dressing, VeraFill Dental Collagen Wound Dressing, bone grafting material, animal source and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Animal Source | NPM | 2 | Contract manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Contract manufacturer | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | Manufacturer | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2025 | K242100 | SurgiAid Collagen Wound Dressing (HA) | KGN | Substantially Equivalent | Maxigen Biotech, Inc. | accessdata.fda.gov |
| November 22, 2023 | K230529 | HealiAid Dental Collagen Wound Dressing | OLR | Substantially Equivalent | Maxigen Biotech, Inc. | accessdata.fda.gov |
| October 11, 2023 | K223126 | SurgiAid® Collagen Wound Dressing | KGN | Substantially Equivalent | Maxigen Biotech, Inc. | accessdata.fda.gov |
| February 2, 2011 | K100927 | SURGIAID | KGN | Substantially Equivalent | Maxigen Biotech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Grafting Material, Animal Source
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Splint, Intranasal Septal
- All makers of Oral Wound Dressing
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated October 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.