FDA Registration
Active
🇲🇾 Malaysia
Synergy Sterilisation Rawang (m) Sdn. Bhd.
Reg #: 3010175289
·
FEI: 3010175289
·
Expires 2026
Products
12
Proprietary Names
6
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- Synergy Sterilisation Rawang (m) Sdn. Bhd.
- Registration Number
- 3010175289
- FEI Number
- 3010175289
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 42, Jalan Industri 2/1, Rawang Integrated Industrial Park
- City
- Rawang Selangor
- Country
- MY
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2024-12-19 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2013-03-26 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-01-03 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2013-03-26 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-04-17 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-03-26 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2013-03-22 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-06-27 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2013-11-08 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2025-02-12 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-01-24 |
Proprietary Names
BDPTE (RW) - BD Eclipse Injection Needle with BD Luer-Lok Syringe
WRP10943 (RW,KK) - Signature Latex Ortho
Rover35148 (VL) - Rovers Anex Brush
SteripackPoland (RB,DK,VL2,) - Sterile Flocked Swab; Sterile Foam Swab; SteriPack Sterile Polyester Spun Swab and Swab
SteriPack9541 (RB,DK,VL2) - Sterile Polyester Spun Swab
Rover35148 (VL) - Rovers Evalyn Brush
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)