# Guangzhou Fortunique Limited · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Guangzhou Fortunique Limited · 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 Probe Cover; ultrasound | Probe Cover; ultrasound; product code is 80 M - - MP Cover, Barrier, Protective | 90 I - - TX Transducer, Ultrasonic, Diagnostic; date published is 08/15/2018; address is Building 4 , No. 202 Shiyulu; Fanyu , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Fortunique Limited _(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:** Building 4 , No. 202 Shiyulu; Fanyu , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 08/15/2018 _(verified: appears in the quote below)_
- **Product code:** 80 M - - MP Cover, Barrier, Protective | 90 I - - TX Transducer, Ultrasonic, Diagnostic _(verified: each item appears in the quote below)_
- **Product:** Probe Cover; ultrasound | Probe Cover; ultrasound _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device without a valid 501K. For PC 80MMP; only ultrasound probe covers are subject to DWPE under this listing. | Class II device without a valid 501K. _(verified: each item appears in the quote below)_

## What the source says

> Guangzhou Fortunique Limited Date Published : 08/15/2018 Building 4 , No. 202 Shiyulu; Fanyu , Guangzhou, Guangdong CHINA 80 M - - MP Cover, Barrier, Protective Date Published: 08/15/2018 Desc: Probe Cover; ultrasound Notes: Class II device without a valid 501K. For PC 80MMP; only ultrasound probe covers are subject to DWPE under this listing. 90 I - - TX Transducer, Ultrasonic, Diagnostic Date Published: 08/15/2018 Desc: Probe Cover; ultrasound Notes: Class II device without a valid 501K.

## 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/).