FDA Registration
Active
🇲🇾 Malaysia
SUPERCOMAL MEDICAL PRODUCTS, SDN BHD
Reg #: 3004832480
·
FEI: 3004832480
·
Expires 2026
Products
18
Proprietary Names
15
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- SUPERCOMAL MEDICAL PRODUCTS, SDN BHD
- Registration Number
- 3004832480
- FEI Number
- 3004832480
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 171,JALAN PKNK 3/8,KAWASAN, PERUSAHAAN, SUNGAI PETANI
- City
- SUNGAI PETANI Kedah
- Country
- MY
Owner / Operator
- Firm Name
- SUPERCOMAL MEDICAL PRODUCTS, SDN BHD
- Operator Number
- 9065891
- Address
- LOT 172,JALAN PKNK 3/8,KAWASAN, PERUSAHAAN, SUNGAI PETANI
- City
- SUNGAI PETANI, KEDAH D.A.
- State
- MY-NOTA
- Postal Code
- 08000
- Country
- MY
US Agent
- Business Name
- BENTLEY BIOMEDICAL CONSULTING, LLC.
- Contact Name
- SHEPARD BENTLEY
- Address
- 29461 TROON STREET
- City
- Laguna Beach
- State
- CA
- ZIP
- 92677
- Country
- US
- [email protected]
- Phone
- 949 4954274
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2016-12-21 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2016-12-21 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2015-10-31 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2015-10-31 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2015-10-31 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2020-05-12 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2019-04-30 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2020-06-30 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2017-08-01 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2020-06-15 |
| Cerebral Oximeter | QEM | Class 2 | Cardiovascular | No | 2025-03-31 |
| Catheter, Oximeter, Fiber-Optic | DQE | Class 2 | Cardiovascular | No | 2025-03-31 |
| Adjunctive Open Loop Fluid Therapy Recommender | QMS | Class 2 | Cardiovascular | No | 2025-03-31 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-03-31 |
| Medium-Term Adjunctive Predictive Cardiovascular Indicator | QNL | Class 2 | Cardiovascular | No | 2025-03-31 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2025-03-31 |
| Adjunctive Predictive Cardiovascular Indicator | QAQ | Class 2 | Cardiovascular | No | 2025-03-31 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2025-03-31 |
Proprietary Names
EV1000 Clinical Platform With ClearSight Finger Cuff Or ClearSight System, EV1000 Clinical Platform
TruWave Disposable Pressure Transducer Cable
EDSLAB Closed Injectate Delivery System Cable
Model VIG2 Monitor Cable
Ambu Neuroline Monopolar Cable
Ambu Neuroline Concentric Cable
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
Beautiful Image Body Sculpting Model 900
CBL CO-Set Injectate Temp Probe LOA
EV1000 Clinical Platfom Cable
D*Clot HD Rotational Thrombectomy Catheter
Alta Swan
HEMAPSC200
HEMA70CC2
PSC2 Alta
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)