FOSUN TRADING (HK) COMPANY LIMITED · 89-08 · HONG KONG SAR
For FOSUN TRADING (HK) COMPANY LIMITED · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is Dr. Pen Auto Microneedle System A6 | Dr. Pen Advanced Microneedling System Ultima-A6; product code is 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device; date published is 06/30/2025; address is Unit 9a, 2/F, Block B, Hoplite , Industrial Centre, 3-5 Wang Tai , Hong Kong, HONG KONG SAR, verified against its source on 2026-09-16.
- Firm
- FOSUN TRADING (HK) COMPANY LIMITED 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
- HONG KONG SAR verified
- Address
- Unit 9a, 2/F, Block B, Hoplite , Industrial Centre, 3-5 Wang Tai , Hong Kong, HONG KONG SAR verified
- Date published
- 06/30/2025 verified
- Product code
- 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device each item verified
- Product
- Dr. Pen Auto Microneedle System A6 | Dr. Pen Advanced Microneedling System Ultima-A6 each item verified
What the source says
FOSUN TRADING (HK) COMPANY LIMITED Date Published : 06/30/2025 Unit 9a, 2/F, Block B, Hoplite , Industrial Centre, 3-5 Wang Tai , Hong Kong, HONG KONG SAR 79 Q - - AI Powered microneedle device Date Published: 06/30/2025 Desc: Dr. Pen Auto Microneedle System A6 79 Q - - AI Powered microneedle device Date Published: 06/30/2025 Desc: Dr. Pen Advanced Microneedling System Ultima-A6
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.