Bridget Lifescience Co Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Bridget Lifescience Co Ltd, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 2026-09-30.
- 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)
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html