FDA Registration
Active
🇲🇾 Malaysia
GeneXpert Xpress System
Reg #: 3007923088
·
FEI: 3007923088
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sanmina-SCI Systems (Malaysia) Sdn Bhd
- Registration Number
- 3007923088
- FEI Number
- 3007923088
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 202 Lorong Perushaan Maju 9, Bukit Tengah Industrial Park
- City
- Perai Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K180218
Owner / Operator
- Firm Name
- Sanmina Corporation
- Operator Number
- 2129538
- Address
- 13000 S. Memorial Pkwy, --
- City
- Huntsville
- State
- AL
- Postal Code
- 35803
- Country
- US
US Agent
- Business Name
- Sanmina Corporation
- Contact Name
- Jeffrey Stahl
- Address
- 13000 S Memorial Pkwy
- City
- Huntsville
- State
- AL
- ZIP
- 35803
- Country
- US
- [email protected]
- Phone
- 256 4794797
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2024-04-04 |
Proprietary Names
GeneXpert Xpress System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)