SHENYANG AERTI TECH CO.,LTD.
China CN-MF-000014272 Last updated 8 Jun 2026
- Devices
- 19
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Medical Oxygen Concentrator Ref AE-3-N
Medical Oxygen Concentrator Ref AE-5
Medical Oxygen Concentrator Ref AE-8
Medical Oxygen Concentrator Ref AE-8-N
Medical Oxygen Concentrator Ref AE-5-S
Medical Oxygen Concentrator Ref AE-8-NW
Medical Oxygen Concentrator Ref AE-5-NW
Medical Oxygen Concentrator Ref AE-3
Medical Oxygen Concentrator Ref AR-3-N
Medical Oxygen Concentrator Ref AE-5-W
Medical Oxygen Concentrator Ref AE-8-W
Medical Oxygen Concentrator Ref AE-3-S
Medical Oxygen Concentrator Ref AE-8-S
Medical Oxygen Concentrator Ref AR-5
Medical Oxygen Concentrator Ref AE-3-NW
Medical Oxygen Concentrator Ref AE-3-W
Medical Oxygen Concentrator Ref AE-5-N
Medical Oxygen Concentrator Ref AR-3
Medical Oxygen Concentrator Ref AR-5-N
EUDAMED certificates
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2175876-1 Issued
Quality management system EU MDR
- Issued
- 7 Nov 2025
- Expires
- 6 Nov 2030
Related companies
Notified bodies
What SHENYANG AERTI TECH CO.,LTD. makes
Shenyang Aerti Tech Co., Ltd. manufactures medical oxygen concentrators designed for clinical and home-use applications, delivering concentrated oxygen from ambient air for respiratory therapy.
These devices are classified as Class IIb under EU regulations and are listed in the EUDAMED database. The manufacturer is based in China.
Frequently asked questions
What types of medical devices does Shenyang Aerti Tech Co., Ltd. manufacture?
Shenyang Aerti Tech Co., Ltd. specializes in producing medical oxygen concentrators, which are devices that extract and concentrate oxygen from ambient air to provide a continuous supply for respiratory therapy. These devices are designed for both clinical and home-use settings, ensuring patients have access to concentrated oxygen when needed.
Where is Shenyang Aerti Tech Co., Ltd. based?
The company is headquartered in China, specifically in Shenyang. This location reflects its operational base for manufacturing, research, and distribution of its medical devices.
Which regulatory registries list Shenyang Aerti Tech Co., Ltd.’s devices?
Shenyang Aerti Tech Co., Ltd.’s medical oxygen concentrators are listed in the EUDAMED database, which is the European Union’s medical device registry. This listing helps ensure transparency and traceability of devices marketed within the EU.
How are Shenyang Aerti Tech Co., Ltd.’s medical oxygen concentrators classified under EU regulations?
Under EU medical device regulations, Shenyang Aerti Tech Co., Ltd.’s medical oxygen concentrators are classified as Class IIb. This classification is determined based on factors like the device’s intended use, potential risks, and the need for additional scrutiny to ensure safety and performance, such as through clinical evaluations or special controls.
Information
- Country
- China
- Address
- No.77-1, 13th Road, Shenyang Economic & Technological Development Area, Shenyang City, China
- Website
- www.aerti.com.cn
- [email protected]
- Phone
- +86-24-3122 9971 ext. 8002
- PRRC contact
- Wang Wenbin
- EUDAMED SRN
- CN-MF-000014272