# FOSUN TRADING (HK) COMPANY LIMITED · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** HONG KONG SAR _(verified: appears in the quote below)_
- **Address:** Unit 9a, 2/F, Block B, Hoplite , Industrial Centre, 3-5 Wang Tai , Hong Kong, HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 06/30/2025 _(verified: appears in the quote below)_
- **Product code:** 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device _(verified: each item appears in the quote below)_
- **Product:** Dr. Pen Auto Microneedle System A6 | Dr. Pen Advanced Microneedling System Ultima-A6 _(verified: each item appears in the quote below)_

## 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

## 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/).