Reference Source

Apoza Enter Co Ltd · 89-08 · TAIWAN

For Apoza Enter Co Ltd, import alert is 89-08; country is TAIWAN; 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 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 2026-09-30.

Firm
Apoza Enter 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
TAIWAN verified
Address
6f No 657 Chung , Taipei Hsien, TAIWAN verified
Date published
09/07/2010 verified
Product code
80 F - - LE Sterilizer, Steam verified
Product
New Clave Autohouse AD& (Non-Vacuum Type) verified
FDA notes
Class II, AD7 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Apoza Enter Co Ltd Date Published : 09/07/2010 6f No 657 Chung , Taipei Hsien, TAIWAN

— 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

80 F - - LE Sterilizer, Steam Date Published: 09/07/2010 Desc: New Clave Autohouse AD& (Non-Vacuum Type) Notes: Class II, AD7

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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