Guangzhou Fortunique Limited · 89-08 · CHINA
For Guangzhou Fortunique Limited, 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 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 2026-09-30.
- Firm
- Guangzhou Fortunique Limited 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
- Building 4 , No. 202 Shiyulu; Fanyu , Guangzhou, Guangdong CHINA verified
- Date published
- 08/15/2018 verified
- Product code
- 80 M - - MP Cover, Barrier, Protective | 90 I - - TX Transducer, Ultrasonic, Diagnostic each item verified
- Product
- Probe Cover; ultrasound | Probe Cover; ultrasound each item verified
- 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. each item verified
What the source says
Guangzhou Fortunique Limited Date Published : 08/15/2018 Building 4 , No. 202 Shiyulu; Fanyu , 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
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.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html