FDA Registration
Active
🇭🇰 Hong Kong
Blood-Alcohol Tester: AP036, AP038, AP039, FiT240, FiT333, FiT032, FiT228-LC, AT230, AT229, FiT303, AT002, FiT088
Reg #: 3014302776
·
FEI: 3014302776
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- A&A PRODUCT MANUFACTURING LIMITED
- Registration Number
- 3014302776
- FEI Number
- 3014302776
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Workshop 9, 18/F, Tower A, New Trade Plaza, 6 On Ping Street
- City
- ShaTin,New Territories
- Country
- HK
Owner / Operator
- Firm Name
- A&A Product Manufacturing Limited
- Operator Number
- 10056778
- Address
- Workshop 9, 18/F, Tower A, New Trade Plaza, 6 On Ping Street
- City
- ShaTin,New Territories
- State
- HK-NOTA
- Postal Code
- 00000
- Country
- HK
US Agent
- Business Name
- REGISTRAR CORP
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | Class 1 | Clinical Toxicology | No | 2018-01-15 |
Proprietary Names
Blood-Alcohol Tester: AP036, AP038, AP039, FiT240, FiT333, FiT032, FiT228-LC, AT230, AT229, FiT303, AT002, FiT088
Breath-Alcohol Tester: ALCOPATROL AP338, AP4020, AP8020, AP8080, AT007, AT010, AT011, AP012, AP013, AP015, AP018, AP035,
Breath-Alcohol Tester: FiT198, FiT148, FiT233
AP5020, ALCOCAM , AP037, AP601, AP602, AP203, AP147, AP205
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device