BOMTECH ELECTRONICS CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- Address
- 322, Gonghang-daero, , Gangseo-gu , Seoul, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF) verified
- Date published
- 05/08/2020 verified
- Product code
- 79 Q - - AI Powered microneedle device | 80 F - - MI Needle, Hypodermic, Single Lumen each item verified
- Product
- Tri-M Micro Needle | Tri-M Micro Needle each item verified
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
— 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.