Getinge 46-SERIES
WASHER DISINFECTOR 46-5 S+W D, S+W D indicating a single door washer disinfector with dryer. This is a customized version of 46-5-402 with water inlet through the roof plate and signal…
WASHER DISINFECTOR 46-5 S+W D, S+W D indicating a single door washer disinfector with dryer. This is a customized version of 46-5-402 with water inlet through the roof plate and signal exchange for external valve for treated water.
9manufacturers in China registered for this device type
12catalogue numbers in this listing
8recalls on this code
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 | Getinge Disinfection AB, Sweden |
|---|---|
| FDA product code | MEC |
| Device type | Disinfector, Medical Devices |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6992 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-03-06 |
| Record revised | 2025-10-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 46-4 | In distribution | |
| 46-4 | In distribution | |
| 46-4 | In distribution | |
| 46-5 | In distribution | |
| 46-5 | In distribution | |
| 46-5 | In distribution | |
| 46-4 | In distribution | |
| 46-5 | In distribution | |
| 46-4T, 46-5T | In distribution | |
| 46-5 | In distribution | |
| 46-4 | In distribution | |
| 46-5 | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Maquet Cardiovascular Us Sales, Llc | UDI-DI | 2020-01-16 | Class III | Employee error | Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have bee | 4 units | 2023-10-23 |
| Maquet Cardiovascular Us Sales, Llc | UDI-DI | 2020-01-16 | Class III | Employee error | Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have bee | 7 units | 2023-10-23 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. 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 |
|---|---|---|---|---|---|
| 2025-08-29 | Class II | Under Investigation by firm | Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered. | 902 units | |
| 2025-04-02 | Class II | Under Investigation by firm | The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump ho | 424 units (79 US, 345 OUS) | |
| 2025-04-02 | Class II | Under Investigation by firm | The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump ho | 102 units (8 US, 94 OUS) | |
| 2018-03-02 | Class II | Software design | There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment. | 170 total products | 2022-05-13 |
| 2018-03-02 | Class II | Software design | There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment. | 170 total products | 2022-05-13 |
| 2015-06-26 | Class III | Software Manufacturing/Software Deployment | Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network. | 20 devices | 2018-05-23 |
| 2014-11-26 | Class II | Device Design | Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has iden | 551 total: USA: 547 units, Canada: 4 units | 2017-05-12 |
| 2013-07-30 | Class II | Nonconforming Material/Component | Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating. | 143 units (142 domestically & 1 unit internationally) | 2015-05-11 |
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.