Reference Source

HANDSOME INDUSTRIAL (H.K.) CO., LTD · 89-08 · CHINA

For HANDSOME INDUSTRIAL (H.K.) CO., LTD · 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 Microneedle roller | Microneedle roller; product code is 79 M - - DM Instrument, Manual, General Surgical | 88 K - - JB Apparatus, Roller; date published is 09/04/2013; address is No. 155, Xinhua Rd., Hudua District , Guongzhou , Guangdong, GUANGDONG CHINA, verified against its source on 2026-09-16.

Firm
HANDSOME INDUSTRIAL (H.K.) CO., LTD 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. 155, Xinhua Rd., Hudua District , Guongzhou , Guangdong, GUANGDONG CHINA verified
Date published
09/04/2013 verified
Product code
79 M - - DM Instrument, Manual, General Surgical | 88 K - - JB Apparatus, Roller each item verified
Product
Microneedle roller | Microneedle roller each item verified
FDA notes
class III | Class III each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

HANDSOME INDUSTRIAL (H.K.) CO., LTD Date Published : 09/04/2013 No. 155, Xinhua Rd., Hudua District , Guongzhou , Guangdong, GUANGDONG CHINA 79 M - - DM Instrument, Manual, General Surgical Date Published: 09/04/2013 Desc: Microneedle roller Notes: class III 88 K - - JB Apparatus, Roller Date Published: 09/04/2013 Desc: Microneedle roller Notes: Class III

accessdata.fda.gov, retrieved 2026-09-15

Source

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