FDA Registration
Active
🇲🇾 Malaysia
SINA-STERILGAMMA SDN BHD
Reg #: 3010280860
·
FEI: 3010280860
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SINA-STERILGAMMA SDN BHD
- Registration Number
- 3010280860
- FEI Number
- 3010280860
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 88077, Jalan Perigi Nenas 7/1, Taman Perindustrian, Pulau Indah
- City
- Pelabuhan Klang Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K093409
Owner / Operator
- Firm Name
- SINA-SterilGamma Sdn Bhd
- Operator Number
- 10043035
- Address
- Lot 88077, Jalan Perigi Nenas 7/1, Taman Perindustrian, Pulau Indah
- City
- Pelabuhan Klang
- State
- Selangor
- Postal Code
- 42907
- Country
- MY
US Agent
- Business Name
- mdi Consultants, Inc.
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd Ste 200
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-02-05 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)