FDA device listing
Embedding Cassette; Biopsy Foam Pads; Embedding Rings; Storage Drawer; Tissue Capsules
FDA device listing 1819208027 · BOEN HEALTHCARE CO., LTD.
Key facts
| Proprietary names | Embedding Cassette; Biopsy Foam Pads; Embedding Rings; Storage Drawer; Tissue Capsules |
|---|---|
| Owner/operator | BOEN HEALTHCARE CO., LTD. |
| Owner/operator number | 10095691 |
| Product codes | IDZ |
| Device names | IDZ - Cassettes, Tissue |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3010 |
| Review panels | Pathology |
| Registered establishments | BOEN HEALTHCARE CO., LTD. |
| Establishment registrations | 3045058049 |
| FEI numbers | 3045058049 |
| Establishment operations | Foreign Exporter, Specification Developer |
| 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