FDA device listing
SureThin sample vials with fixative solution, Safe Prep sample vials with fixative solution
FDA device listing 1638158586 · MEDITE Medical GmbH
Key facts
| Proprietary names | SureThin sample vials with fixative solution, Safe Prep sample vials with fixative solution |
|---|---|
| Owner/operator | MEDITE Medical GmbH |
| Owner/operator number | 10088477 |
| Product codes | NNI |
| Device names | NNI - Container, Specimen, Non-Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3250 |
| Review panels | Pathology |
| Registered establishments | MEDITE MEDICAL GMBH |
| Establishment registrations | 3004594181 |
| FEI numbers | 3004594181 |
| 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