Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · 89-08 · CHINA
For Shenzhen Biocare Bio-Medical 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html