FDA device listing
AERMEI AMV Laser Imaging Film 125SH 20X25CM (8X10IN) AMV,AERMEI AMV Laser Imaging Film 125SH 25X30CM (10X12IN)…
FDA device listing 1917934637 · Carestream Health, Inc.
Key facts
| Proprietary names | AERMEI AMV Laser Imaging Film 125SH 20X25CM (8X10IN) AMV,AERMEI AMV Laser Imaging Film 125SH 25X30CM (10X12IN) AMV,AERMEI AMV Laser Imaging Film 125SH 28X35CM (11X14IN) AMV,AERMEI AMV Laser Imaging Film 125SH 35X43CM (14X17IN) AMV,DRYVIEW DVB+ Laser Imaging Film,DRYVIEW DVB+ Premium Laser Imaging Film,DRYVIEW DVE Laser Imaging Film,DRYVIEW DVM Mammography Laser Imaging Film,DRYVIEW DVM+… |
|---|---|
| Owner/operator | Carestream Health, Inc. |
| Owner/operator number | 9097221 |
| Product codes | IWZ |
| Device names | IWZ - Film, Radiographic |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.1840 |
| Review panels | Radiology |
| Registered establishments | Carestream Health, Inc, Carestream Health, Inc., Rayco (Xiamen) Medical Products Company Limited |
| Establishment registrations | 1317267, 1317307, 3029911, 3003578745 |
| FEI numbers | 1317267, 1317307, 1000524463, 3003578745 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| 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