# ENANO HEALTH LTD · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Unit 623 Biotech Ctr 2 , Pak Shek Kok Nt, HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 05/31/2022 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** Saliva Glucose Tracker | Saliva Glucose Tracker | Saliva Glucose Tracker | Saliva Glucose Tracker _(verified: each item appears in the quote below)_

## 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

## Source

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

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).