# HANDSOME INDUSTRIAL (H.K.) CO., LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: 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. 155, Xinhua Rd., Hudua District , Guongzhou , Guangdong, GUANGDONG CHINA _(verified: appears in the quote below)_
- **Date published:** 09/04/2013 _(verified: appears in the quote below)_
- **Product code:** 79 M - - DM Instrument, Manual, General Surgical | 88 K - - JB Apparatus, Roller _(verified: each item appears in the quote below)_
- **Product:** Microneedle roller | Microneedle roller _(verified: each item appears in the quote below)_
- **FDA notes:** class III | Class III _(verified: each item appears in the quote below)_

## 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

## 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/).