# MEDITIME CO., LTD · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** # 605 Medical Complex , 200 Gieopdosi Road, Jieong Myeon , Wonju, Gangwon KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 06/17/2025 _(verified: appears in the quote below)_
- **Product code:** 79 N - - EW Suture, Surgical, Absorbable, Polydioxanone _(verified: appears in the quote below)_
- **Product:** Viola Threads- PDO- TWIST 29G 38MM _(verified: appears in the quote below)_
- **FDA notes:** Class II device; requires 510(k) _(verified: appears in the quote below)_

## 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)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).