# Shenzen Carewell Electronics Co. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenzen Carewell Electronics Co. · 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 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 2026-09-16.

- **Firm:** Shenzen Carewell Electronics Co. _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 5a Huating 3 Guangye Rd , Shenzhen, FN CHINA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 85 H - - EM Imager, Ultrasonic Obstetric-Gynecologic | 90 L - - XE Doppler, Fetal, Ultrasound | 90 M - - AA Monitor, Fetal Doppler Ultrasound _(verified: each item appears in the quote below)_
- **Product:** Ultrasound Scanner | Ultrasound Scanner | Ultrasound Scanner _(verified: each item appears in the quote below)_
- **FDA notes:** DWPE Date 11/8/2007 | DWPE Date 11/8/2007 | DWPE Date 11/8/2007 _(verified: each item appears in the quote below)_

## What the source says

> Shenzen Carewell Electronics Co. Date Published : 09/16/2009 5a Huating 3 Guangye Rd , Shenzhen, FN CHINA 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).