# GUANGZHOU BAIYUN DISTRICT HANDAELECTRONICS FACTOR · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For GUANGZHOU BAIYUN DISTRICT HANDAELECTRONICS FACTOR · 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 Mole Removal Pen; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories; date published is 06/06/2018; address is No. 1 Baiyun Distr , Shajing East Road, Taihe Town , Guangzhou, CHINA, verified against its source on 2026-09-16.

- **Firm:** GUANGZHOU BAIYUN DISTRICT HANDAELECTRONICS FACTOR _(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. 1 Baiyun Distr , Shajing East Road, Taihe Town , Guangzhou, CHINA _(verified: appears in the quote below)_
- **Date published:** 06/06/2018 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories _(verified: appears in the quote below)_
- **Product:** Mole Removal Pen _(verified: appears in the quote below)_

## What the source says

> GUANGZHOU BAIYUN DISTRICT HANDAELECTRONICS FACTOR Date Published : 06/06/2018 No. 1 Baiyun Distr , Shajing East Road, Taihe Town , Guangzhou, CHINA 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 06/06/2018 Desc: Mole Removal Pen

## 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/).