M.I. TECH · 89-08 · KOREA (THE REPUBLIC OF)
For M.I. TECH, 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 CytoPen Nano Pen | CytoPen Nano Pen; product code is 79 G - - FE Brush, Dermabrasion | 79 Q - - AI Powered microneedle device; date published is 04/12/2023; address is 65 #616, Hanshin S-Meca , Yuseong, DAEJEON KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- M.I. TECH 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
- 65 #616, Hanshin S-Meca , Yuseong, DAEJEON KOREA (THE REPUBLIC OF) verified
- Date published
- 04/12/2023 verified
- Product code
- 79 G - - FE Brush, Dermabrasion | 79 Q - - AI Powered microneedle device each item verified
- Product
- CytoPen Nano Pen | CytoPen Nano Pen each item verified
What the source says
M.I. TECH Date Published : 04/12/2023 65 #616, Hanshin S-Meca , Yuseong, DAEJEON 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 G - - FE Brush, Dermabrasion Date Published: 04/12/2023 Desc: CytoPen Nano Pen 79 Q - - AI Powered microneedle device Date Published: 04/12/2023 Desc: CytoPen Nano Pen
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html