Shenzhen Aeon Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 5 device types, 2 products catalogued, 3 clearances.
Shenzhen Aeon Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Compressor, Air, Portable and 3 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | SHENZHEN AEON TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008830133 |
| FEI number | 3008830133 |
| DUNS | 529372064 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市正生技术有限公司 |
|---|---|
| Unified social credit code | 91440300792561227J |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | A301, Building A, No. 5003, Bao’an Avenue |
| Postal code | 518126 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | Electronic Thermometer A260, A261, A262, A263, A264, A265 | 2025 | 49 |
| Compressor, Air, Portable | Class 2 | Compressor Nebulizer A500LWD01,A500LWD02,A500LWD04,A500LWD05,A500LWDC01,A500LWDC02,A500LWDC04,A500LWDC05 | 2016 | 23 |
| Continuous Measurement Thermometer | Class 2 | Infrared Thermometer A200,A201,A202,A201F,A201W,A202W,A202C,A202D,A202E,A202F | 2017 | 115 |
| Oximeter | Class 2 | Fingertip pulse oximeter A300,A310,A320,A330,A340,A350,A310L,A330N,A340L,A310E, Fingertip Pulse Oximeter A310B, A330B, A340B, Fingtip Pulse Oximeter A310 | 2017 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | Pulse Oximeter A310E, A320E, A330E, A340E, A310, A350, A350E, A370E, A371E, AIMO1, AIMO2 | 2018 | 29 |
Own-Brand Listings
Clearances
3 clearances name Shenzhen Aeon Technology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K200414 | 2020-09-23 | DQA | Traditional | This company |
| K190869 | 2019-09-13 | DQA | Traditional | This company |
| K171578 | 2017-11-30 | FLL | Traditional | This company |
| K153021 | 2016-11-22 | DQA | Traditional | Amemo, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Employees | 101-200 |
| Main products | Patient Monitors, Fetal Monitors, Pulse Oximeter, Fetal Doppler, Infrared Thermometer |
| Certifications | ISO13485, CE |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.