FDA Registration
Active
🇹🇼 Taiwan
BRITEMED TECHNOLOGY INC.
Reg #: 3012843412
·
FEI: 3012843412
·
Expires 2026
Products
10
Proprietary Names
18
Establishment Types
1
Classifications
10
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Registration Details
- Registration Name
- BRITEMED TECHNOLOGY INC.
- Registration Number
- 3012843412
- FEI Number
- 3012843412
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3F., No. 306,306-3, 13F., No. 306,306-3, Sec. 1, Datong Rd., Xizhi Dist.,
- City
- New Taipei City
- Country
- TW
Owner / Operator
- Firm Name
- BriteMED Technology Inc.
- Operator Number
- 10062321
- Address
- 3F., No. 306,306-3, 13F., No. 306,306-3, Sec. 1, Datong Rd., Xizhi Dist.,
- City
- New Taipei City
- State
- TW-TPE
- Postal Code
- 221
- Country
- TW
- Correspondent
- Janet Lu
US Agent
- Business Name
- IEI Technology USA Corporation
- Contact Name
- Paul Tseng
- Address
- 138 university pkwy, pomona, CA 91768
- City
- Pomona
- State
- CA
- ZIP
- 91768
- Country
- US
- [email protected]
- Phone
- 909 5952819 ext. 115
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2020-01-12 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2023-08-18 |
| Laryngoscope Kit | OGH | Class 1 | Anesthesiology | No | 2025-12-03 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2023-11-02 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2023-11-02 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-10-28 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2024-06-25 |
| Duodenoscope And Accessories, Flexible/Rigid | FDT | Class 2 | Gastroenterology, Urology | No | 2024-04-19 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2024-04-09 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2024-12-10 |
Proprietary Names
Ambu aBox 2; Ambu aScope 5 Broncho HD 5/2.2; Ambu aScope 5 Broncho HD 5.6/2.8
Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance
Ambu® SureSight® Mobile Mini Kit
Ambu® SureSight® Mobile Kit
Ambu® aScope Colon
Ambu® aBox 2
Ambu® aScope 5 Ureteroscope
Ambu® aBox 2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2
Ambu aBox 2; Ambu aScope Duodeno 2
Ambu® aScope Gastro Large; Ambu® aBox 2
Ambu® ABox2
Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance
aView 2 Advance
Ambu® aView 2 Advance
Ambu® SureSight® Data Cable
Ambu® SureSight® Charger
Ambu® SureSight® Connect
Ambu® SureSight® Mobile
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)