# Bridget Lifescience Co Ltd · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 12th Fl., Shinwoong Tower , 719 Yeoksam2-Dong , Gangnam-Gu, SEOUL TEUGBYEOLSI KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 11/30/2011 _(verified: appears in the quote below)_
- **Product code:** 78 N - - ZU Collector, urine, powered, non indwelling catheter _(verified: appears in the quote below)_
- **Product:** Careclean 3000 Personal automatic urine collection system _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## 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

## 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/).