# Gemc Techonology · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Gemc Techonology · 89-08 · CHINA, 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 CHINA; 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 2026-09-16.

- **Firm:** Gemc Techonology _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** NO. 20 Bosong Lu , Jinshui , Zhengzhou, Henan CHINA _(verified: appears in the quote below)_
- **Date published:** 02/29/2016 _(verified: appears in the quote below)_
- **Product code:** 75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter _(verified: appears in the quote below)_
- **Product:** Pregnancy Test Kits _(verified: appears in the quote below)_

## What the source says

> Gemc Techonology Date Published : 02/29/2016 NO. 20 Bosong Lu , Jinshui , Zhengzhou, Henan CHINA 75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter Date Published: 02/29/2016 Desc: Pregnancy Test Kits

## 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/).