FDA device listing
Alta Swan,HEMA70CC2,HEMAPSC200,PSC2 Alta
FDA device listing 1187812729 · SUPERCOMAL MEDICAL PRODUCTS, SDN BHD
Key facts
| Proprietary names | Alta Swan,HEMA70CC2,HEMAPSC200,PSC2 Alta |
|---|---|
| Owner/operator | SUPERCOMAL MEDICAL PRODUCTS, SDN BHD |
| Owner/operator number | 9065891 |
| Product codes | DQE, DSB, DXN, DYG, FLL, MUD, QAQ, QEM, QMS, QNL |
| Device names | DQE - Catheter, Oximeter, Fiber-Optic, DSB - Plethysmograph, Impedance, DXN - System, Measurement, Blood-Pressure, Non-Invasive, DYG - Catheter, Flow Directed, FLL - Continuous Measurement Thermometer, MUD - Oximeter, Tissue Saturation, QAQ - Adjunctive Predictive Cardiovascular Indicator, QEM - Cerebral Oximeter, QMS - Adjunctive Open Loop Fluid Therapy Recommender, QNL - Medium-Term Adjunctive Predictive Cardiovascular Indicator |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1130, 870.1230, 870.1240, 870.2210, 870.2700, 870.2770, 870.5600, 880.2910 |
| Review panels | Cardiovascular, General Hospital |
| Registered establishments | SUPERCOMAL MEDICAL PRODUCTS, SDN BHD |
| Establishment registrations | 3004832480 |
| FEI numbers | 3004832480 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database