Amsco

The AMSCO 7053L Single-Chamber Washer/Disinfector meets the demands for the highest-volume sterile processing departments. It is designed for cleaning and intermediate-level disinfection of…

Registry build 21.09.26

The AMSCO 7053L Single-Chamber Washer/Disinfector meets the demands for the highest-volume sterile processing departments. It is designed for cleaning and intermediate-level disinfection of soiled reusable utensils, trays, bedpans and urinals. It can also be used for rubber and plastic goods, simple hard-surfaced rigid surgical instruments (such as forceps and clamps) and other similar and related articles found in healthcare facilities.

9manufacturers in China registered for this device type
69catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code MEC
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

Regulatory record for Amsco
Listed by Corporation Steris Canada
FDA product code MEC
Device type Disinfector, Medical Devices
Device class Class 2
Regulation 21 CFR 880.6992
Premarket notification Exempt
Record published 2020-09-04
Record revised 2023-11-21 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries manufacturing date, serial number
Distribution end date 2026-04-02

Catalogue Numbers

Catalogue numbers for Amsco
Catalogue number Size Status
2532 In distribution
1215 In distribution
2532 In distribution
3052 In distribution
2532 In distribution
3052 In distribution
2532 In distribution
2532 In distribution
2532 In distribution
1215 In distribution
2532 In distribution
2532 In distribution
3052 In distribution
2532 In distribution
1215 In distribution
2532 In distribution
5052 In distribution
7052HP In distribution
7052HP In distribution
3052 In distribution
2532 In distribution
2532 In distribution
7052HP In distribution
7053HP In distribution
5052 In distribution
7052HP In distribution
3052 In distribution
5052 In distribution
5052 In distribution
2532 In distribution
3052 In distribution
7052HP In distribution
1215 In distribution
2532 In distribution
2532 In distribution
1215 In distribution
5052 In distribution
2532 In distribution
1215 In distribution
7053HP In distribution
2532 In distribution
7053HP In distribution
1215 In distribution
7053HP In distribution
3052 In distribution
2532 In distribution
5052 In distribution
2532 In distribution
2532 In distribution
7052HP In distribution
2532 In distribution
7053HP In distribution
5052 In distribution
5052 In distribution
1215 In distribution
2532 In distribution
2532 In distribution
2532 In distribution
7053HP In distribution
1215 In distribution
3052 In distribution
7053L Withdrawn
7053L Withdrawn
7053L Withdrawn
7053L Withdrawn
7053L Withdrawn
7053L Withdrawn
5052 Withdrawn
7053L Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Steelco Steelco SPA 106
Disinfector, Medical Devices Corporation Steris Canada 76
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
Getinge 46-SERIES Getinge Disinfection AB 12

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.

Recalls naming the identifiers of Amsco
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Steris Corporation UDI-DI 2025-11-19 Class II Process control Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users). 10
Steris Corporation UDI-DI 2025-11-19 Class II Process control Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users). 22

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer