Reference Source

Wintek Microcircuit Corp · 89-08 · TAIWAN

For Wintek Microcircuit Corp · 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 code is 80 F - - LL Thermometer, Electronic, Clinical; date published is 09/16/2009; address is #51 Cheng Teh Road , Taipei, TAIWAN, verified against its source on 2026-09-16.

Firm
Wintek Microcircuit Corp 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
#51 Cheng Teh Road , Taipei, TAIWAN verified
Date published
09/16/2009 verified
Product code
80 F - - LL Thermometer, Electronic, Clinical verified
FDA notes
Pacifier Thermometer 3/9/1994. Trade Name Dubby verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Wintek Microcircuit Corp Date Published : 09/16/2009 #51 Cheng Teh Road , Taipei, TAIWAN 80 F - - LL Thermometer, Electronic, Clinical Date Published: 09/16/2009 Notes: Pacifier Thermometer 3/9/1994. Trade Name Dubby

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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