Data / Medical devices / Taiwan / 3D Global Biotech Inc.
3D Global Biotech Inc.: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
3D Global Biotech Inc. is registered with the FDA (registration 3031092085) in New Taipei City, Taiwan. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031092085
- Address
- 21F.-1, No.99, Sec. 1, Xintai 5th Rd., New Taipei City, Taiwan, 22175
- Owner or operator
- 3D Global Biotech Inc. (10090574)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 14, 2024
- Registered through
- 2026
- Brand names listed
- EZ-i Former, ExoLens, ExoMate, EyeMate, HairMatt, LensMate, Wound Mate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Exporter to the US | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Exporter to the US | accessdata.fda.gov |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| May 13, 2022 | K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | LPL | Substantially Equivalent | Innova Vision, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Media And Components, Synthetic Cell And Tissue Culture
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lens, Contact, (Disposable)
Updated May 13, 2022. 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.