ONETECH MEDICAL EQUIPMENT CO LIM · 89-08 · CHINA
For ONETECH MEDICAL EQUIPMENT CO LIM · 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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