FDA Registration
Active
🇸🇬 Singapore
Merit Medical Singapore Pte. Ltd.
Reg #: 8020616
·
FEI: 3002806476
·
Expires 2026
Products
13
Proprietary Names
23
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- Merit Medical Singapore Pte. Ltd.
- Registration Number
- 8020616
- FEI Number
- 3002806476
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 198 YISHUN AVE. 7
- City
- SINGAPORE Central Singapore
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K941428
Owner / Operator
- Firm Name
- Merit Medical Systems, Inc.
- Operator Number
- 1721504
- Address
- 1600 West Merit Parkway, --
- City
- South Jordan
- State
- UT
- Postal Code
- 84095
- Country
- US
US Agent
- Business Name
- Merit Medical Systems, Inc.
- Contact Name
- John Knorpp
- Address
- 1600 West Merit Parkway
- City
- South Jordan
- State
- UT
- ZIP
- 84095
- Country
- US
- [email protected]
- Phone
- 801 2084795
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2017-02-17 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2017-02-17 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2017-02-17 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2017-02-17 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2017-02-17 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2017-02-17 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2017-02-17 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2017-02-17 |
| Actuator, Syringe, Injector Type | DQF | Class 2 | Cardiovascular | No | 2017-02-17 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2017-02-17 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2017-02-17 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2017-02-17 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2017-02-17 |
Proprietary Names
Exacta Percutaneous Sheath Introducer
Integral Injectate Temperature Probe
Catheter Connection Cable
Disposable In Line Sensor Housing
Safedraw Blood Sampling System
Secalon T Catheter
Careflow Central Venous Catheter
ROSE
Tubing, Fluid Delivery
Critiflo Dome
Critiflo
Connecta PE Lines
Spectraject Control Syringe
Critikit Plus In-Line Room/ Ice Injectate
DTX Disposable Temperature Probe
DTX/DTX Plus Kit and Accessories
DTX Plus Disposable Pressure Transducer
SafT Needle Direct Blood Transfer
RadialFlo
Bath Probe
Catheter Connection Cables and Cardia Computer
Injectate Sensor Cable
Pressure Tubing
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility