FDA Registration
Active
🇲🇾 Malaysia
STERIPACK ASIA SDN BHD
Reg #: 3009988302
·
FEI: 3009988302
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIPACK ASIA SDN BHD
- Registration Number
- 3009988302
- FEI Number
- 3009988302
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 119992, Jalan Canang Emas 8,, Telok Gong
- City
- Klang Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K192991
Owner / Operator
- Firm Name
- SteriPack Asia Sdn Bhd
- Operator Number
- 10043162
- Address
- Lot 119992, Jalan Canang Emas 8,, Telok Gong
- City
- Klang
- State
- Selangor
- Postal Code
- 42000
- Country
- MY
- Correspondent
- Wai Woon Khoo
US Agent
- Business Name
- SteriPack USA (Limited) LLC
- Contact Name
- Marinela Cebic
- Address
- 4255 S Pipkin Rd
- City
- Lakeland
- State
- FL
- ZIP
- 33811
- Country
- US
- [email protected]
- Phone
- 863 6482333
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2020-09-07 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)