# ONETECH MEDICAL EQUIPMENT CO LIM · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 19 YINGBIN , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 08/07/2017 _(verified: appears in the quote below)_
- **Product code:** 90 E - - HD Unit, X-Ray, Extraoral With Timer | 90 M - - UH System, X-Ray, Extraoral Source, Digital _(verified: each item appears in the quote below)_
- **Product:** Dental X Ray Machine | Dental X Ray Machine _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).