# Amata Medicare Co., Ltd. · 89-08 · THAILAND — FDA import alert red lists: firms subject to detention without physical examination

For Amata Medicare Co., Ltd. · 89-08 · THAILAND, 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 THAILAND; product is Loss of Resistance Syringe (Glass); product code is 80 F - - MF Syringe, Piston; date published is 02/07/2023; address is 117/14, 117/33 , Moo 5; Bangphai , Muang Nonthaburi, Nonthaburi THAILAND, verified against its source on 2026-09-16.

- **Firm:** Amata Medicare 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:** THAILAND _(verified: appears in the quote below)_
- **Address:** 117/14, 117/33 , Moo 5; Bangphai , Muang Nonthaburi, Nonthaburi THAILAND _(verified: appears in the quote below)_
- **Date published:** 02/07/2023 _(verified: appears in the quote below)_
- **Product code:** 80 F - - MF Syringe, Piston _(verified: appears in the quote below)_
- **Product:** Loss of Resistance Syringe (Glass) _(verified: appears in the quote below)_

## What the source says

> Amata Medicare Co., Ltd. Date Published : 02/07/2023 117/14, 117/33 , Moo 5; Bangphai , Muang Nonthaburi, Nonthaburi THAILAND 80 F - - MF Syringe, Piston Date Published: 02/07/2023 Desc: Loss of Resistance Syringe (Glass)

## 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/).