M.I. TECH · 89-08 · KOREA (THE REPUBLIC OF)
For M.I. TECH · 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 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 2026-09-16.
- 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) 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
— 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.