Guangzhou Fortunique Limited · 89-08 · CHINA
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
- 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 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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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