BOMTECH ELECTRONICS CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
For BOMTECH ELECTRONICS CO., LTD., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 2026-09-30.
- 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)
— 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 and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html