Reference Source

GUANGZHOU BAIYUN DISTRICT HANDAELECTRONICS FACTOR · 89-08 · CHINA

For GUANGZHOU BAIYUN DISTRICT HANDAELECTRONICS FACTOR, 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 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 2026-09-30.

Firm
GUANGZHOU BAIYUN DISTRICT HANDAELECTRONICS FACTOR 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. 1 Baiyun Distr , Shajing East Road, Taihe Town , Guangzhou, CHINA verified
Date published
06/06/2018 verified
Product code
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories verified
Product
Mole Removal Pen verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— 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

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 06/06/2018 Desc: Mole Removal Pen

— 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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