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