FDA device listing
VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD),V-PRO 60 Low Temperature Sterilization System (MY-CFE),V-PRO S2…
FDA device listing 1053303879 · STERIS Corporation
Key facts
| Proprietary names | VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD),V-PRO 60 Low Temperature Sterilization System (MY-CFE),V-PRO S2 Low Temperature Sterilization System (MY-MF, CM-SD) |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Premarket submissions | K182568 |
| Product codes | MLR |
| Device names | MLR - Sterilizer, Chemical |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6860 |
| Review panels | General Hospital |
| Registered establishments | STERIS Corporation, STERIS CORPORATION, STERIS MEXICO, S. de R.L. de C.V. |
| Establishment registrations | 1527821, 3003950207, 3005899764 |
| FEI numbers | 1527821, 3003950207, 3005899764 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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