FDA Registration
Active
🇹🇼 Taiwan
TRONJEN MEDICAL TECHNOLOGY INC
Reg #: 9616572
·
FEI: 3003661715
·
Expires 2026
Products
9
Proprietary Names
31
Establishment Types
2
Classifications
9
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Registration Details
- Registration Name
- TRONJEN MEDICAL TECHNOLOGY INC
- Registration Number
- 9616572
- FEI Number
- 3003661715
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5F, No. 63, Jingke Central road
- City
- Nantun Dist. Taichung
- Country
- TW
Owner / Operator
- Firm Name
- TRONJEN MEDICAL TECHNOLOGY INC
- Operator Number
- 10022940
- Address
- 5F, No. 63, Jingke Central road
- City
- Nantun Dist
- State
- Taichung
- Postal Code
- 408018
- Country
- TW
- Correspondent
- Sunny Ku
US Agent
- Business Name
- Baoni International Inc.
- Contact Name
- Baosheng Lee
- Address
- 3990 Bridlewood Drive, Duluth, GA 30096
- City
- Berkeley Lake
- State
- GA
- ZIP
- 30096
- Country
- US
- [email protected]
- Phone
- 678 4676822
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2019-05-23 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2019-05-23 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2022-07-15 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2019-12-26 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2019-12-24 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2022-07-15 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2024-02-16 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2007-10-24 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2025-12-08 |
Proprietary Names
Surgical Hydrogel Dressing
Waterproof Island Dressing
Hydrocolloid Dressing
Foam Dressing
Waterproof Film Dressing
Gauze Pad
Skin Barrier
Pressure relief pad
Hydrogel wound dressing
H&H Wound Gel
Wound Gel
GelSkin
H&H
Comfopore
Surgical skin degreaser or adhesive tape solvent
Adhesive Release Spray
Waterproof Bandage
First Aid Tape
Plaster Strip
First Aid kits
Waterproof Film
First Aid Bandage
Hydrogel Wound Dressing
Hydrocolloid bandage
Dressing Retaintion Roll
Plaster for Knuckles and Fingers
Island Dressing
Plaster for Eye
Scar Care Sheet
Scar Care Silicone Gel
Scar Care Dressing
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)