FDA Registration
Active
🇸🇬 Singapore
semperguard force blue
Reg #: 3010605427
·
FEI: 3010605427
·
Expires 2025
Products
4
Proprietary Names
13
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- HARPS Investment Asia Pte. Ltd.
- Registration Number
- 3010605427
- FEI Number
- 3010605427
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9 Straits View, #08-10A, Marina One West Tower
- City
- Singapore Central Singapore
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K223903
Owner / Operator
- Firm Name
- HARPS Investment Asia Pte. Ltd.
- Operator Number
- 10045460
- Address
- 9 Straits View, #08-10A, Marina One West Tower
- City
- Singapore
- State
- SG-NOTA
- Postal Code
- 018937
- Country
- SG
US Agent
- Business Name
- Mansour Consulting LLC
- Contact Name
- Jay Mansour
- Address
- 845 Aronson Lake Court
- City
- Roswell
- State
- GA
- ZIP
- 30075
- Country
- US
- [email protected]
- Phone
- 678 9088180
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-02-27 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-02-27 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-02-27 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-02-27 |
Proprietary Names
semperguard force blue
Tender Touch NBR PF VB 200 pc
SemperForce Blue Nitrile NBR PF OB 100pc
Nitrile Exam 200 NBR PF VB 200pc (IMCO)
StarMed Select NBR PF VB 100pc
Nitrile SPK-035VB NBR PF VB 6pc SP (Sample Gloves)
StarMed Plus NBR PF VB 300pc
Quality Choice Nitrile Exam NBR PF VB
Nitrile SPK-030VB NBR PF VB 6pc SP (Sample Glove)
StarMed Ultra Nitrile NBR PF VB 250pc
Nitrile Exam NBR PF OB (IMCO)
Tender Touch NBR PF VB 100pc M
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Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device