FDA device listing
HP300 Automatic tissue processor,HP300 Plus Automatic tissue processor,HP-HUGO Automatic tissue processor
FDA device listing 2028180782 · Dakewe(Shenzhen) medical equipment Co., Ltd
Key facts
| Proprietary names | HP300 Automatic tissue processor,HP300 Plus Automatic tissue processor,HP-HUGO Automatic tissue processor |
|---|---|
| Owner/operator | Dakewe(Shenzhen) medical equipment Co., Ltd |
| Owner/operator number | 10059546 |
| Product codes | IEO |
| Device names | IEO - Processor, Tissue, Automated |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3875 |
| Review panels | Pathology |
| Registered establishments | DAKEWE(SHENZHEN) MEDICAL EQUIPMENT CO., LTD |
| Establishment registrations | 3015167933 |
| FEI numbers | 3015167933 |
| 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