FDA Registration
Active
🇲🇾 Malaysia
STERIPACK ASIA SDN BHD
Reg #: 3009988302
·
FEI: 3009988302
·
Expires 2026
Products
10
Proprietary Names
11
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- STERIPACK ASIA SDN BHD
- Registration Number
- 3009988302
- FEI Number
- 3009988302
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 119992, Jalan Canang Emas 8,, Telok Gong
- City
- Klang Selangor
- Country
- MY
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 |
|---|---|---|---|---|---|
| Tenaculum, Uterine | HDC | Class 2 | Obstetrics/Gynecology | No | 2023-03-24 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-01-29 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2013-01-29 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2025-01-14 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-01-14 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-06-22 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2020-09-07 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2023-03-09 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-04-17 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2021-02-03 |
Proprietary Names
Carevix
Double Pump Day Cassette
Double Pump Single
Double Pump RF Patient Cassette
Double Pump Patient Cassette
CarbonMini
CarbonAid
BIOBRANE Dressing
BIOBRANE Glove
GoLIF! Lumbar Interbody Fusion System
Sterile Polyester Spun Swab
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)