Atmos

The ATMOS S 201 Thorax drainage system is a device for mobile, digital thoracic drainage. The device is meant for the short-term (< 30 days) application on humans. It is portable, mains…

Registry build 21.09.26

The ATMOS S 201 Thorax drainage system is a device for mobile, digital thoracic drainage. The device is meant for the short-term (< 30 days) application on humans. It is portable, mains independent and has an electronic monitoring system with optical and acoustic status display.

14manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (1), elsewhere (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BTA
Manufacturer City Province Registered as Device types
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Avita (Wujiang) Co., Ltd. Wujiang Jiangsu Contract manufacturer 15
Shenzhen BI-Rich Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9
Shenzhen Desida Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Zhongshan A&E Machinery Industry Co., Ltd. Zhongshan Guangdong Manufacturer 25
Shenzhen Hugemed Medical Technical Development Co., Ltd. Shenzhen Guangdong Manufacturer 22
Laerdal Medical (Suzhou) Co., Ltd. 215009 Suzhou Jiangsu Province Repacker / relabeller 12
Dikaku Industrial Co., Limited Hong Kong Hong Kong Private-label distributor 9
Medcodes Healthcare (Shenzhen) Limited Shenzhen Guangdong Manufacturer 9
Shenzhen Root Innovation Technology Co., Ltd. Shenzhen Guangdong Specification developer 8
Hetaida Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 8
Zhongshan A&J Medical Equipment Co., Ltd. Guangdong Guangdong Manufacturer 7

Showing 12 of 14. All 14 manufacturers in China registered for Pump, Portable, Aspiration (Manual Or Powered)

Record

Regulatory record for Atmos
Listed by Atmos Medizintechnik Gmbh & Co. KG, Germany
FDA product code BTA
Device type Pump, Portable, Aspiration (Manual Or Powered)
Device class Class 2
Regulation 21 CFR 878.4780
Establishment Repacker / relabeller, Manufacturer, Exporter
510(k) K090445
Record published 2017-09-27
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Atmos
Catalogue number Size Status
C 451 In distribution
C 051 Thorax In distribution
S 201 Thorax In distribution
C 361 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
R&D Batteries, Inc. R & D Batteries, Inc. 104
Gomco Allied Medical LLC 62
Pump, Portable, Aspiration (Manual Or Powered) Söring GmbH 23
Silicone tubing Medela LLC 10
Grownsy Oak Tech LLC 8
Nasal aspirator Shenzhen Dongjiang Technology Co., Ltd. 8
Thopaz Medela LLC 6
Precision Medical Inc. Precision Medical Technologies 6
Basen Dongguan Yiyingmei Technology Co., Ltd. 6
V7 Hersill SL 6
Care-E-VAC Hersill SL 6
Sscor Quickdraw® Sscor, Inc. 5

Showing 12 of 216. All products under Pump, Portable, Aspiration (Manual Or Powered)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K241799 2025-03-07

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