# TRONLINK TECHNOLOGY CO.,LTD · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For TRONLINK TECHNOLOGY CO.,LTD · 89-08 · TAIWAN, 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 TAIWAN; product is Skin tag Removal kit; product code is 79 G - - DJ Clamp, Surgical, General & Plastic Surgery; date published is 10/04/2017; address is No.444 , 2, 3 F.; Jianguo N. Rd. Sec. 1; Zhongshan Dist. , Taipei City, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** TRONLINK TECHNOLOGY 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:** TAIWAN _(verified: appears in the quote below)_
- **Address:** No.444 , 2, 3 F.; Jianguo N. Rd. Sec. 1; Zhongshan Dist. , Taipei City, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 10/04/2017 _(verified: appears in the quote below)_
- **Product code:** 79 G - - DJ Clamp, Surgical, General & Plastic Surgery _(verified: appears in the quote below)_
- **Product:** Skin tag Removal kit _(verified: appears in the quote below)_
- **FDA notes:** Class I device without a valid 510K _(verified: appears in the quote below)_

## What the source says

> TRONLINK TECHNOLOGY CO.,LTD Date Published : 10/04/2017 No.444 , 2, 3 F.; Jianguo N. Rd. Sec. 1; Zhongshan Dist. , Taipei City, TAIWAN 79 G - - DJ Clamp, Surgical, General & Plastic Surgery Date Published: 10/04/2017 Desc: Skin tag Removal kit Notes: Class I device without a valid 510K

## 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/).