HANDSOME INDUSTRIAL (H.K.) CO., LTD · 89-08 · CHINA
For HANDSOME INDUSTRIAL (H.K.) CO., LTD, 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 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 2026-09-30.
- 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
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
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html