MEDITIME CO., LTD · 89-08 · KOREA (THE REPUBLIC OF)
For MEDITIME 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 Viola Threads- PDO- TWIST 29G 38MM; product code is 79 N - - EW Suture, Surgical, Absorbable, Polydioxanone; date published is 06/17/2025; address is # 605 Medical Complex , 200 Gieopdosi Road, Jieong Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- MEDITIME 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
- # 605 Medical Complex , 200 Gieopdosi Road, Jieong Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF) verified
- Date published
- 06/17/2025 verified
- Product code
- 79 N - - EW Suture, Surgical, Absorbable, Polydioxanone verified
- Product
- Viola Threads- PDO- TWIST 29G 38MM verified
- FDA notes
- Class II device; requires 510(k) verified
What the source says
MEDITIME CO., LTD Date Published : 06/17/2025 # 605 Medical Complex , 200 Gieopdosi Road, Jieong Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF) 79 N - - EW Suture, Surgical, Absorbable, Polydioxanone Date Published: 06/17/2025 Desc: Viola Threads- PDO- TWIST 29G 38MM Notes: Class II device; requires 510(k)
— 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.