Pioway Medical Lab Equipment Co. Ltd. · 89-08 · CHINA
For Pioway Medical Lab Equipment Co. Ltd. · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Digital Ultrasound Scanner | Digital Ultrasound Scanner; product code is 90 I - - TX Transducer, Ultrasonic, Diagnostic | 90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic; date published is 03/10/2014; address is Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA, verified against its source on 2026-09-16.
- Firm
- Pioway Medical Lab Equipment Co. Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA verified
- Date published
- 03/10/2014 verified
- Product code
- 90 I - - TX Transducer, Ultrasonic, Diagnostic | 90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic each item verified
- Product
- Digital Ultrasound Scanner | Digital Ultrasound Scanner each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Pioway Medical Lab Equipment Co. Ltd. Date Published : 03/10/2014 Xinwanli Bldg Room 615A , NO. 9 Baixialu , Nanjing, Jiangsu CHINA 90 I - - TX Transducer, Ultrasonic, Diagnostic Date Published: 03/10/2014 Desc: Digital Ultrasound Scanner Notes: Class II 90 I - - YO System, Imaging, Pulsed Echo, Ultrasonic Date Published: 03/10/2014 Desc: Digital Ultrasound Scanner Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.