FDA Registration
Active
🇭🇰 Hong Kong
Alcoreal AT560
Reg #: 3007776657
·
FEI: 3007766657
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SKYFINE INC. LIMITED
- Registration Number
- 3007776657
- FEI Number
- 3007766657
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15/F., Dundas Square, 43H Dundas Street, Mongkok
- City
- KLN
- Country
- HK
Owner / Operator
- Firm Name
- SKYFINE Inc. Limited
- Operator Number
- 10029263
- Address
- 15/F., Dundas Square, 43H Dundas Street, Mongkok
- City
- KLN
- State
- HK-NOTA
- Postal Code
- 999077
- Country
- HK
- Correspondent
- Jason Chiang
US Agent
- Business Name
- SkyfineUSA inc.
- Contact Name
- Ali Najib
- Address
- 11585 South State Street,
- City
- Draper
- State
- UT
- ZIP
- 84020
- Country
- US
- [email protected]
- Phone
- 801 8658910
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | Class 1 | Clinical Toxicology | No | 2014-03-17 |
Proprietary Names
Alcoreal AT560
Alcoreal AT575
Alcoreal i-551
Alcoreal i-552
Alcoreal AT572
Alcoreal i-553
Alcoreal AT573
Alcoreal i-550
Alcoreal AT571
Alcoreal AT601, AT602, AT567, AT568
AlcoREAL i560, AlcoREAL AT561, AlcoREAL AT588, AlcoREAL AT586, AlcoREAL Cobra588, AlcoREAL ATCOM, DD1000-C
Alcoreal AT562, Alcoreal AT563, Alcoreal AT564, Alcoreal AT565, Alcoreal AT603, Alcoreal AT604, Alcoreal AT605
Cobra555, Ethylec, Ethyway V2, Ethyway Pro, Pro-Tec Ketostat
Alcoreal AT606, Alcoreal RS588, Alcoreal F2
APC-80, APC-81, APC-82, APC-90, I-Alco Supreme, Cobra589, AT607, AT608
VT588, QS588, QS589, COBRA556
Cobra600, Cobra666, AlcoREAL AT550
i-ALCO DOT, i-567, i-574
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device