FDA device listing
Oral swabs
FDA device listing 1835792730 · Changzhou Newrise Medical & Hygiene Products Co., Ltd
Key facts
| Proprietary names | Oral swabs |
|---|---|
| Owner/operator | Changzhou Newrise Medical & Hygiene Products Co., Ltd |
| Owner/operator number | 10060096 |
| Product codes | KXF |
| Device names | KXF - Applicator, Absorbent Tipped, Non-Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6025 |
| Review panels | General Hospital |
| Registered establishments | CHANGZHOU NEWRISE MEDICAL & HYGIENE PRODUCTS CO., LTD |
| Establishment registrations | 3015337373 |
| FEI numbers | 3015337373 |
| Establishment operations | Contract Manufacturer, 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