# Apoza Enter Co Ltd · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For Apoza Enter Co Ltd · 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 New Clave Autohouse AD& (Non-Vacuum Type); product code is 80 F - - LE Sterilizer, Steam; date published is 09/07/2010; address is 6f No 657 Chung , Taipei Hsien, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** Apoza Enter 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:** TAIWAN _(verified: appears in the quote below)_
- **Address:** 6f No 657 Chung , Taipei Hsien, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 09/07/2010 _(verified: appears in the quote below)_
- **Product code:** 80 F - - LE Sterilizer, Steam _(verified: appears in the quote below)_
- **Product:** New Clave Autohouse AD& (Non-Vacuum Type) _(verified: appears in the quote below)_
- **FDA notes:** Class II, AD7 _(verified: appears in the quote below)_

## What the source says

> Apoza Enter Co Ltd Date Published : 09/07/2010 6f No 657 Chung , Taipei Hsien, TAIWAN 80 F - - LE Sterilizer, Steam Date Published: 09/07/2010 Desc: New Clave Autohouse AD& (Non-Vacuum Type) Notes: Class II, AD7

## 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/).