FDA device listing
Annexure 12
FDA device listing 1289934499 · Himedia Laboratories Private Limited
Key facts
| Proprietary names | Annexure 12 |
|---|---|
| Owner/operator | Himedia Laboratories Private Limited |
| Owner/operator number | 9073586 |
| Product codes | KIT |
| Device names | KIT - Media And Components, Synthetic Cell And Tissue Culture |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.2220 |
| Review panels | Hematology |
| Registered establishments | HIMEDIA LABORATORIES PRIVATE LIMITED |
| Establishment registrations | 3005182157, 3005182159 |
| FEI numbers | 3005182157, 3005182159 |
| Establishment operations | 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