Reference Source

TRONLINK TECHNOLOGY CO.,LTD · 89-08 · TAIWAN

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
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
Address
No.444 , 2, 3 F.; Jianguo N. Rd. Sec. 1; Zhongshan Dist. , Taipei City, TAIWAN verified
Date published
10/04/2017 verified
Product code
79 G - - DJ Clamp, Surgical, General & Plastic Surgery verified
Product
Skin tag Removal kit verified
FDA notes
Class I device without a valid 510K verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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