Shenzen Carewell Electronics Co. · 89-08 · CHINA
For Shenzen Carewell Electronics Co., import alert is 89-08; country is CHINA; 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)"; product is Ultrasound Scanner | Ultrasound Scanner | Ultrasound Scanner; product code is 85 H - - EM Imager, Ultrasonic Obstetric-Gynecologic | 90 L - - XE Doppler, Fetal, Ultrasound | 90 M - - AA Monitor, Fetal Doppler Ultrasound; date published is 09/16/2009; address is 5a Huating 3 Guangye Rd , Shenzhen, FN CHINA, verified against its source on 2026-09-30.
- Firm
- Shenzen Carewell Electronics Co. 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
- 5a Huating 3 Guangye Rd , Shenzhen, FN CHINA verified
- Date published
- 09/16/2009 verified
- Product code
- 85 H - - EM Imager, Ultrasonic Obstetric-Gynecologic | 90 L - - XE Doppler, Fetal, Ultrasound | 90 M - - AA Monitor, Fetal Doppler Ultrasound each item verified
- Product
- Ultrasound Scanner | Ultrasound Scanner | Ultrasound Scanner each item verified
- FDA notes
- DWPE Date 11/8/2007 | DWPE Date 11/8/2007 | DWPE Date 11/8/2007 each item verified
What the source says
Shenzen Carewell Electronics Co. Date Published : 09/16/2009 5a Huating 3 Guangye Rd , Shenzhen, FN CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
85 H - - EM Imager, Ultrasonic Obstetric-Gynecologic Date Published: 08/25/2023 Desc: Ultrasound Scanner Notes: DWPE Date 11/8/2007 90 L - - XE Doppler, Fetal, Ultrasound Date Published: 08/25/2023 Desc: Ultrasound Scanner Notes: DWPE Date 11/8/2007 90 M - - AA Monitor, Fetal Doppler Ultrasound Date Published: 08/25/2023 Desc: Ultrasound Scanner Notes: DWPE Date 11/8/2007
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html