Reference Source

CARDICARE COMPANY LTD. · 89-08 · CHINA (Wushan , Hangzhou, Zhejiang CHINA)

For CARDICARE COMPANY LTD. (Wushan , Hangzhou, Zhejiang CHINA), 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 Single Patient Use Aneroid Sphygmomanometer | Medic-Kit5 EMT Kit; product code is 74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive | 74 D - - XQ Cuff, Blood-Pressure; date published is 11/24/2021; address is Wushan , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-30.

Firm
CARDICARE COMPANY LTD. 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
Wushan , Hangzhou, Zhejiang CHINA verified
Date published
11/24/2021 verified
Product code
74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive | 74 D - - XQ Cuff, Blood-Pressure each item verified
Product
Single Patient Use Aneroid Sphygmomanometer | Medic-Kit5 EMT Kit each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

CARDICARE COMPANY LTD. Date Published : 11/24/2021 Wushan , Hangzhou, Zhejiang 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 and Product

74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive Date Published: 11/24/2021 Desc: Single Patient Use Aneroid Sphygmomanometer 74 D - - XQ Cuff, Blood-Pressure Date Published: 10/27/2023 Desc: Medic-Kit5 EMT Kit

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

Source

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

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