ONETECH MEDICAL EQUIPMENT CO LIM · 89-08 · CHINA
For ONETECH MEDICAL EQUIPMENT CO LIM, 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 Dental X Ray Machine | Dental X Ray Machine; product code is 90 E - - HD Unit, X-Ray, Extraoral With Timer | 90 M - - UH System, X-Ray, Extraoral Source, Digital; date published is 08/07/2017; address is 19 YINGBIN , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- ONETECH MEDICAL EQUIPMENT CO LIM 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
- 19 YINGBIN , Guangzhou, Guangdong CHINA verified
- Date published
- 08/07/2017 verified
- Product code
- 90 E - - HD Unit, X-Ray, Extraoral With Timer | 90 M - - UH System, X-Ray, Extraoral Source, Digital each item verified
- Product
- Dental X Ray Machine | Dental X Ray Machine each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
ONETECH MEDICAL EQUIPMENT CO LIM Date Published : 08/07/2017 19 YINGBIN , Guangzhou, Guangdong 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
90 E - - HD Unit, X-Ray, Extraoral With Timer Date Published: 11/08/2018 Desc: Dental X Ray Machine Notes: Class II 90 M - - UH System, X-Ray, Extraoral Source, Digital Date Published: 08/07/2017 Desc: Dental X Ray Machine Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html