ENANO HEALTH LTD · 89-08 · HONG KONG SAR
For ENANO HEALTH LTD, import alert is 89-08; country is HONG KONG SAR; 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 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 2026-09-30.
- 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
What the source says
ENANO HEALTH LTD Date Published : 05/31/2022 Unit 623 Biotech Ctr 2 , Pak Shek Kok Nt, HONG KONG SAR
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html