FDA Registration
Active
🇹🇼 Taiwan
3D GLOBAL BIOTECH INC.
Reg #: 3031092085
·
FEI: 3031092085
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- 3D GLOBAL BIOTECH INC.
- Registration Number
- 3031092085
- FEI Number
- 3031092085
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 21F.-1, No.99, Sec. 1, Xintai 5th Rd.,
- City
- New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K213119
Owner / Operator
- Firm Name
- 3D Global Biotech Inc.
- Operator Number
- 10090574
- Address
- 21F.-1, No.99, Sec. 1, Xintai 5th Rd.,
- City
- New Taipei City
- State
- TW-TPE
- Postal Code
- 22175
- Country
- TW
- Correspondent
- Peng Yu-Quan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media And Components, Synthetic Cell And Tissue Culture | KIT | Class 1 | Hematology | No | 2024-04-14 |
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2025-02-04 |
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2025-02-04 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2024-05-02 |
Proprietary Names
ExoMate
HairMatt
Wound Mate
EZ-i Former
LensMate
ExoLens
EyeMate
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device