Mamoray HDR-C Plus
Catalogue number MAMORAY HDR-C PLUS 18x24, listed by Agfa Healthcare Inc., Canada, under Film, Radiographic. 3 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Rayco (Xiamen) Medical Products Company Limited | Xiamen | Fujian | Contract manufacturer | 1 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
Record
| Listed by | Agfa Healthcare Inc., Canada |
|---|---|
| FDA product code | IWZ |
| Device type | Film, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1840 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 4 to 25 °C; Special storage condition: Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom. |
| Packaging | Pack of 5 |
| Sizes | Length 18 cm; width 24 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MAMORAY HDR-C PLUS 18×24 | Length 18 cm | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gafchromic™ | Ashland Specialty Ingredients, G.P. | 151 |
| Dryview DVB Laser Imaging Film | Carestream Health, Inc. | 42 |
| Imaging Plates | Palodex Group OY | 24 |
| Henry Schein | Henry Schein, Inc. | 24 |
| Fuji Medical X-RAY Film | Fujifilm Corporation | 21 |
| Ultra-speed | Carestream Health, Inc. | 17 |
| T-MAT G/RA Film | Carestream Health, Inc. | 16 |
| Dryview DVM Mammography Laser Imaging Film | Carestream Health, Inc. | 16 |
| E Blue X-ray Film WB | Carestream Health, Inc. | 15 |
| Medical X-ray Green / MXG Film | Carestream Health, Inc. | 15 |
| Rad Control | Typenex Medical, LLC | 15 |
| Insight | Carestream Health, Inc. | 15 |
Showing 12 of 259. All products under Film, Radiographic
Recalls
2 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-10-24 | Class III | Other | Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed. | 142 units | 2015-03-16 |
| 2014-07-16 | Class III | Process design | Some sheets of the medical screen film are fogged. | 2617 | 2014-12-09 |
| 2011-10-04 | Not classified | Process control | The film notch was located in the wrong position. | 125 | 2011-12-22 |
| 2010-03-02 | Not classified | Error in labeling | Labeling problem | 2 boxes | 2012-02-14 |
| 2006-02-16 | Not classified | Other | The film was incorrectly notched. | 16523 units | 2006-06-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.