Reference Source

Gemc Techonology · 89-08 · CHINA

For Gemc Techonology, import alert is 89-08; country is CHINA; 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 Pregnancy Test Kits; product code is 75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter; date published is 02/29/2016; address is NO. 20 Bosong Lu , Jinshui , Zhengzhou, Henan CHINA, verified against its source on 2026-09-30.

Firm
Gemc Techonology 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
CHINA verified
Address
NO. 20 Bosong Lu , Jinshui , Zhengzhou, Henan CHINA verified
Date published
02/29/2016 verified
Product code
75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter verified
Product
Pregnancy Test Kits verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Gemc Techonology Date Published : 02/29/2016 NO. 20 Bosong Lu , Jinshui , Zhengzhou, Henan CHINA

— 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 and Product

75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter Date Published: 02/29/2016 Desc: Pregnancy Test Kits

— 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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