E-M Medical Treatment And Electron (Suzhou) Co Ltd · 89-08 · CHINA
For E-M Medical Treatment And Electron (Suzhou) Co Ltd, import alert is 89-08; country is CHINA; 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 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 2026-09-30.
- 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
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
— 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, Product and FDA notes
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: ***
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html