Reference Source

ENANO HEALTH LTD · 89-08 · HONG KONG SAR

For ENANO HEALTH LTD · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is Saliva Glucose Tracker | Saliva Glucose Tracker | Saliva Glucose Tracker | Saliva Glucose Tracker; product code is 75 L - - FR Glucose Dehydrogenase, Glucose | 75 N - - BW System, Test, Blood Glucose, Over the Counter | 75 Q - - CD Continuous glucose monitor, implanted, adjunctive use | 88 P - - PM General purpose reagent; date published is 05/31/2022; address is Unit 623 Biotech Ctr 2 , Pak Shek Kok Nt, HONG KONG SAR, verified against its source on 2026-09-16.

Firm
ENANO HEALTH 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
HONG KONG SAR verified
Address
Unit 623 Biotech Ctr 2 , Pak Shek Kok Nt, HONG KONG SAR verified
Date published
05/31/2022 verified
Product code
75 L - - FR Glucose Dehydrogenase, Glucose | 75 N - - BW System, Test, Blood Glucose, Over the Counter | 75 Q - - CD Continuous glucose monitor, implanted, adjunctive use | 88 P - - PM General purpose reagent each item verified
Product
Saliva Glucose Tracker | Saliva Glucose Tracker | Saliva Glucose Tracker | Saliva Glucose Tracker 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

ENANO HEALTH LTD Date Published : 05/31/2022 Unit 623 Biotech Ctr 2 , Pak Shek Kok Nt, HONG KONG SAR 75 L - - FR Glucose Dehydrogenase, Glucose Date Published: 05/31/2022 Desc: Saliva Glucose Tracker 75 N - - BW System, Test, Blood Glucose, Over the Counter Date Published: 05/31/2022 Desc: Saliva Glucose Tracker 75 Q - - CD Continuous glucose monitor, implanted, adjunctive use Date Published: 05/31/2022 Desc: Saliva Glucose Tracker 88 P - - PM General purpose reagent Date Published: 05/31/2022 Desc: Saliva Glucose Tracker

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

Source

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