Miele
This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental…
This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental instruments and laboratory glassware.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Medease Life Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 15 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Aopu Lighting (Jinyun) Co., Ltd. | Lishui | Zhejiang | Contract manufacturer | 9 |
| Dongguan I-Believe Electronic Appliance Co., Ltd. | Dongguan | Guangdong | Manufacturer | 5 |
| Guangdong Eraclean Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 3 |
| Xiamen Forsound Hearing Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 3 |
| Zhongshan Sunclean Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Steelco SPA |
|---|---|
| FDA product code | MEC |
| Device type | Disinfector, Medical Devices |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6992 |
| Premarket notification | Exempt |
| Record published | 2020-06-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PWD 8531 WS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Steelco | Steelco SPA | 106 |
| Disinfector, Medical Devices | Corporation Steris Canada | 76 |
| Amsco | Corporation Steris Canada | 69 |
| Accessory | Getinge Disinfection AB | 64 |
| Sterling P1800 | Skytron, LLC | 43 |
| CleanStart | Skytron, LLC | 31 |
| I-Series Washers | Skytron, LLC | 26 |
| Sterling C2000 | Skytron, LLC | 25 |
| Vision | Corporation Steris Canada | 25 |
| Reliance Vision | Corporation Steris Canada | 24 |
| Sterling Washers | Skytron, LLC | 23 |
| Disinfector, Medical Devices | Medisafe UK Ltd. | 16 |
Showing 12 of 96. All products under Disinfector, Medical Devices
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.