Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · 89-08 · CHINA
For Shenzhen Biocare Bio-Medical Equipment Co., Ltd., 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 BU-908 Electronic Convex Ultrasound Scanner | BU-908 Electronic Convex Ultrasound Scanner | BU-908 Electronic Convex 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 Pingshan , New District 16 Kengzizhen Longgang , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- Shenzhen Biocare Bio-Medical 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
- Pingshan , New District 16 Kengzizhen Longgang , Shenzhen, Guangdong 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
- BU-908 Electronic Convex Ultrasound Scanner | BU-908 Electronic Convex Ultrasound Scanner | BU-908 Electronic Convex Ultrasound Scanner each item verified
- FDA notes
- DWPE Date 12/8/2004 | DWPE Date 12/8/2004 | DWPE Date 12/8/2004 each item verified
What the source says
Shenzhen Biocare Bio-Medical Equipment Co., Ltd. Date Published : 09/16/2009 Pingshan , New District 16 Kengzizhen Longgang , Shenzhen, Guangdong 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: BU-908 Electronic Convex Ultrasound Scanner Notes: DWPE Date 12/8/2004 90 L - - XE Doppler, Fetal, Ultrasound Date Published: 08/25/2023 Desc: BU-908 Electronic Convex Ultrasound Scanner Notes: DWPE Date 12/8/2004 90 M - - AA Monitor, Fetal Doppler Ultrasound Date Published: 08/25/2023 Desc: BU-908 Electronic Convex Ultrasound Scanner Notes: DWPE Date 12/8/2004
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html