Bridget Lifescience Co Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Bridget Lifescience Co Ltd · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Careclean 3000 Personal automatic urine collection system; product code is 78 N - - ZU Collector, urine, powered, non indwelling catheter; date published is 11/30/2011; address is 12th Fl., Shinwoong Tower , 719 Yeoksam2-Dong , Gangnam-Gu, SEOUL TEUGBYEOLSI KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Bridget Lifescience 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 12th Fl., Shinwoong Tower , 719 Yeoksam2-Dong , Gangnam-Gu, SEOUL TEUGBYEOLSI KOREA (THE REPUBLIC OF) verified
- Date published
- 11/30/2011 verified
- Product code
- 78 N - - ZU Collector, urine, powered, non indwelling catheter verified
- Product
- Careclean 3000 Personal automatic urine collection system verified
- FDA notes
- Class II verified
What the source says
Bridget Lifescience Co Ltd Date Published : 11/30/2011 12th Fl., Shinwoong Tower , 719 Yeoksam2-Dong , Gangnam-Gu, SEOUL TEUGBYEOLSI KOREA (THE REPUBLIC OF) 78 N - - ZU Collector, urine, powered, non indwelling catheter Date Published: 11/30/2011 Desc: Careclean 3000 Personal automatic urine collection system 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.