# Kenmajor Ent. Co., · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For Kenmajor Ent. Co., · 89-08 · TAIWAN, 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 TAIWAN; product is Glass Eye Wash Cup | Glass Eye Wash Cup; product code is 52 A - - 36 Tumbler, drinking (container w/o handle, w/o stem & w/o foot)(Foodware/Cookware/Table | 86 L - - XQ Cup, Eye; date published is 06/13/2012; address is Sec.5 Sinty , Taipei City, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** Kenmajor Ent. Co., _(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:** TAIWAN _(verified: appears in the quote below)_
- **Address:** Sec.5 Sinty , Taipei City, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 06/13/2012 _(verified: appears in the quote below)_
- **Product code:** 52 A - - 36 Tumbler, drinking (container w/o handle, w/o stem & w/o foot)(Foodware/Cookware/Table | 86 L - - XQ Cup, Eye _(verified: each item appears in the quote below)_
- **Product:** Glass Eye Wash Cup | Glass Eye Wash Cup _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Kenmajor Ent. Co., Date Published : 06/13/2012 Sec.5 Sinty , Taipei City, TAIWAN 52 A - - 36 Tumbler, drinking (container w/o handle, w/o stem & w/o foot)(Foodware/Cookware/Table Date Published: 06/13/2012 Desc: Glass Eye Wash Cup Notes: Class II 86 L - - XQ Cup, Eye Date Published: 06/13/2012 Desc: Glass Eye Wash Cup 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/).