# BOMTECH ELECTRONICS CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For BOMTECH ELECTRONICS CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Tri-M Micro Needle | Tri-M Micro Needle; product code is 79 Q - - AI Powered microneedle device | 80 F - - MI Needle, Hypodermic, Single Lumen; date published is 05/08/2020; address is 322, Gonghang-daero, , Gangseo-gu , Seoul, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** BOMTECH ELECTRONICS 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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 322, Gonghang-daero, , Gangseo-gu , Seoul, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 05/08/2020 _(verified: appears in the quote below)_
- **Product code:** 79 Q - - AI Powered microneedle device | 80 F - - MI Needle, Hypodermic, Single Lumen _(verified: each item appears in the quote below)_
- **Product:** Tri-M Micro Needle | Tri-M Micro Needle _(verified: each item appears in the quote below)_

## What the source says

> BOMTECH ELECTRONICS CO., LTD. Date Published : 05/08/2020 322, Gonghang-daero, , Gangseo-gu , Seoul, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF) 79 Q - - AI Powered microneedle device Date Published: 05/08/2020 Desc: Tri-M Micro Needle 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2020 Desc: Tri-M Micro Needle

## 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/).