FDA Registration
Active
🇲🇾 Malaysia
Sanmina-SCI Systems (Malaysia) Sdn Bhd
Reg #: 3007923088
·
FEI: 3007923088
·
Expires 2026
Products
5
Proprietary Names
14
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Sanmina-SCI Systems (Malaysia) Sdn Bhd
- Registration Number
- 3007923088
- FEI Number
- 3007923088
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 202 Lorong Perusahaan Maju 9, Bukit Tengah Industrial Park
- City
- Perai Pulau Pinang
- Country
- MY
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
- Contact Name
- Jeffrey Stahl
- Address
- 13000 Memorial Pkwy Sw
- City
- Huntsville
- State
- AL
- ZIP
- 35803
- Country
- US
- [email protected]
- Phone
- 256 8824125
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2023-12-12 |
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2014-01-06 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-08-10 |
| System, Processing For Frozen Blood | KSW | Class 2 | Hematology | No | 2014-01-06 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2025-09-19 |
Proprietary Names
Cell Saver Elite/Elite+
PCS®2
NexSys PCS with Persona PLUS Technology
IntelliBridge EC 40/80
TxLink 2 Connection Module
ASP ACCESS Data Station
ACP¿ 215
NexSys PCS
NexSys, PCS, Express Plus
NexSys PCS Plasma Collection System
9000
Cell Saver Elite device CSE-EW-XX
NexSys, PCS
GeneXpert DX systems
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)