Shandong Chengwu Medical Products Factory · 89-08 · CHINA

For Shandong Chengwu Medical Products Factory, 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 Disposable Virus Specimen Collection Tube | Viral transport media Viral transport tube | Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04 | Disposable Virus Specimen Collection Tube (Preservation solution; Viral Transport Media) Type; CW-01; CW-02; CW-03; CW-04; product code is 80 K - - XG Applicator, Absorbent Tipped, Sterile | 83 J - - SG Culture Media, Non-Selective And Non-Differential | 83 J - - SM Culture Media, Non-Propagating Transport | 83 Q - - MC Transport medium, notified per the VTM guidance; date published is 08/19/2021; address is Southern End Of Quancheng Road, Chengwu County , Heze, Shandong CHINA, verified against its source on 2026-09-30.

What the source says

Shandong Chengwu Medical Products Factory Date Published : 08/19/2021 Southern End Of Quancheng Road, Chengwu County , Heze, Shandong 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.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.