Reference Source

Unimed Medical Supplies Inc · 89-08 · CHINA

For Unimed Medical Supplies Inc · 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 Reusable Adult Ear Clip Sensors (U903-01) Oximeter | Disposable MAS-LINCS Pdtx SpO2 Sensors | Disposable SpO2 Sensors (Oximeters); Nellcor Oximax Compatible | Reusable Adult Ear Clip Sensors (U903-01) Oximeter | Reusable SpO2 Sensors (Oximeters) | Reusable Adult Ear Clip Sensors (U903-01) Oximeter; product code is 73 D - - PZ Oximeter, Ear | 73 D - - QA Oximeter | 73 D - - QA Oximeter | 73 D - - QA Oximeter | 73 D - - QA Oximeter | 73 P - - GJ Oximeter, wellness; date published is 02/09/2022; address is Bldg. 8, Nangang 3rd Industrial Park , Tangtou, Shiyan, Baoan , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.

Firm
Unimed Medical Supplies Inc 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
Bldg. 8, Nangang 3rd Industrial Park , Tangtou, Shiyan, Baoan , Shenzhen, Guangdong CHINA verified
Date published
02/09/2022 verified
Product code
73 D - - PZ Oximeter, Ear | 73 D - - QA Oximeter | 73 D - - QA Oximeter | 73 D - - QA Oximeter | 73 D - - QA Oximeter | 73 P - - GJ Oximeter, wellness each item verified
Product
Reusable Adult Ear Clip Sensors (U903-01) Oximeter | Disposable MAS-LINCS Pdtx SpO2 Sensors | Disposable SpO2 Sensors (Oximeters); Nellcor Oximax Compatible | Reusable Adult Ear Clip Sensors (U903-01) Oximeter | Reusable SpO2 Sensors (Oximeters) | Reusable Adult Ear Clip Sensors (U903-01) Oximeter 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

Unimed Medical Supplies Inc Date Published : 02/09/2022 Bldg. 8, Nangang 3rd Industrial Park , Tangtou, Shiyan, Baoan , Shenzhen, Guangdong CHINA 73 D - - PZ Oximeter, Ear Date Published: 09/21/2022 Desc: Reusable Adult Ear Clip Sensors (U903-01) Oximeter 73 D - - QA Oximeter Date Published: 05/02/2022 Desc: Disposable MAS-LINCS Pdtx SpO2 Sensors 73 D - - QA Oximeter Date Published: 02/09/2022 Desc: Disposable SpO2 Sensors (Oximeters); Nellcor Oximax Compatible 73 D - - QA Oximeter Date Published: 09/21/2022 Desc: Reusable Adult Ear Clip Sensors (U903-01) Oximeter 73 D - - QA Oximeter Date Published: 03/11/2022 Desc: Reusable SpO2 Sensors (Oximeters) Notes: 73 P - - GJ Oximeter, wellness Date Published: 09/21/2022 Desc: Reusable Adult Ear Clip Sensors (U903-01) Oximeter

accessdata.fda.gov, retrieved 2026-09-15

Source

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