FDA Registration
Active
🇹🇼 Taiwan
ALLIANCE INTERNATIONAL MEDICAL CO., LTD.
Reg #: 3006532271
·
FEI: 3006532271
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
3
Classifications
6
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Registration Details
- Registration Name
- ALLIANCE INTERNATIONAL MEDICAL CO., LTD.
- Registration Number
- 3006532271
- FEI Number
- 3006532271
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.54, Yingtao Rd., Yingge Dist.
- City
- NEW TAIPEI CITY
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K082965
Owner / Operator
- Firm Name
- ALLIANCE INTERNATIONAL MEDICAL CO., LTD.
- Operator Number
- 9099902
- Address
- No.54, Yingtao Rd., Yingge Dist.
- City
- New Taipei City
- State
- TW-NWT
- Postal Code
- 23942
- Country
- TW
US Agent
- Business Name
- ROC Chinese-European Industrial Research Society
- Contact Name
- Shu-Chen Cheng
- Address
- 2064 Tamarin Dr
- City
- Columbus
- State
- OH
- ZIP
- 43235
- Country
- US
- [email protected]
- Phone
- 614 5888168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2026-01-22 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2010-03-19 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2010-03-19 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2010-03-19 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2024-04-25 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2024-04-25 |
Proprietary Names
Powered Toothbrush
DS-A Blood Glucose Monitoring Syste
DS-A Sterile Lancets
DS-W Disposable Lancets
Glucose Monitoring System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)