FDA device listing
MEDICAL CHART RECORDING PAPER,ULTRASOUND PAPER THERMAL PRINT MEDIA
FDA device listing 1094642362 · ISD MEDITECH SDN. BHD.
Key facts
| Proprietary names | MEDICAL CHART RECORDING PAPER,ULTRASOUND PAPER THERMAL PRINT MEDIA |
|---|---|
| Owner/operator | ISD MEDITECH SDN. BHD. |
| Owner/operator number | 10090673 |
| Product codes | DSF |
| Device names | DSF - Recorder, Paper Chart |
| Device class | Class I |
| Classification regulations (21 CFR) | 870.2810 |
| Review panels | Cardiovascular |
| Registered establishments | ISD MEDITECH SDN. BHD. |
| Establishment registrations | 3030970187 |
| FEI numbers | 3030970187 |
| Establishment operations | Foreign Private Label Distributor, Manufacturer, Repackager/Relabeler |
| 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