Reference Source

E-M Medical Treatment And Electron (Suzhou) Co Ltd · 89-08 · CHINA

For E-M Medical Treatment And Electron (Suzhou) Co Ltd · 89-08 · CHINA, 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 CHINA; product is Acupuncture Needles; product code is 80 M - - QX Needle, Acupuncture, Single Use; date published is 09/09/2014; address is # 18 Chunqiu Road , Huangdaizhen Xiangcheng , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-16.

Firm
E-M Medical Treatment And Electron (Suzhou) 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
CHINA verified
Address
# 18 Chunqiu Road , Huangdaizhen Xiangcheng , Suzhou, Jiangsu CHINA verified
Date published
09/09/2014 verified
Product code
80 M - - QX Needle, Acupuncture, Single Use verified
Product
Acupuncture Needles verified
FDA notes
***Class II device without a valid 510K DWPE all acupuncture needles, except the following: *** verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

E-M Medical Treatment And Electron (Suzhou) Co Ltd Date Published : 09/09/2014 # 18 Chunqiu Road , Huangdaizhen Xiangcheng , Suzhou, Jiangsu CHINA 80 M - - QX Needle, Acupuncture, Single Use Date Published: 09/09/2014 Desc: Acupuncture Needles Notes: ***Class II device without a valid 510K DWPE all acupuncture needles, except the following: ***

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

Source

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