Reference Source

Amata Medicare Co., Ltd. · 89-08 · THAILAND

For Amata Medicare Co., Ltd., import alert is 89-08; country is THAILAND; 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)"; 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 2026-09-30.

Firm
Amata Medicare 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
THAILAND verified
Address
117/14, 117/33 , Moo 5; Bangphai , Muang Nonthaburi, Nonthaburi THAILAND verified
Date published
02/07/2023 verified
Product code
80 F - - MF Syringe, Piston verified
Product
Loss of Resistance Syringe (Glass) verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Amata Medicare Co., Ltd. Date Published : 02/07/2023 117/14, 117/33 , Moo 5; Bangphai , Muang Nonthaburi, Nonthaburi THAILAND

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

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code and Product

80 F - - MF Syringe, Piston Date Published: 02/07/2023 Desc: Loss of Resistance Syringe (Glass)

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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