FDA Registration
Active
🇲🇾 Malaysia
SINA-STERILGAMMA SDN BHD
Reg #: 3010280860
·
FEI: 3010280860
·
Expires 2026
Products
9
Proprietary Names
4
Establishment Types
3
Classifications
9
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Registration Details
- Registration Name
- SINA-STERILGAMMA SDN BHD
- Registration Number
- 3010280860
- FEI Number
- 3010280860
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 88077, Jalan Perigi Nenas 7/1, Taman Perindustrian, Pulau Indah
- City
- Pelabuhan Klang Selangor
- Country
- MY
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 |
|---|---|---|---|---|---|
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2024-01-08 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2018-03-05 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2013-02-05 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-02-05 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2026-01-07 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2013-01-21 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2026-01-07 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2020-11-30 |
| Tube, Nasogastric | BSS | Class 2 | Gastroenterology, Urology | No | 2013-01-21 |
Proprietary Names
Shield, Protective, Personnel
BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING
Drape, Surgical
ENTERAL FEEDING TUBE
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device