FDA device listing
Bouin's-Collect FIuid,VTM-N Collection and Transport Kit,VTM Collection and Transport Kit,Container, Specimen mailer…
FDA device listing 1291681669 · Hangzhou Rollmed Co.,Ltd.
Key facts
| Proprietary names | Bouin's-Collect FIuid,VTM-N Collection and Transport Kit,VTM Collection and Transport Kit ,Container, Specimen mailer and storage, sterile |
|---|---|
| Owner/operator | Hangzhou Rollmed Co.,Ltd. |
| Owner/operator number | 10053608 |
| Product codes | KDT |
| Device names | KDT - Container, Specimen Mailer And Storage, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | HANGZHOU ROLLMED CO.,LTD. |
| Establishment registrations | 3013530901 |
| FEI numbers | 3013530901 |
| Establishment operations | Foreign Exporter, 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