# Technic Star Universal · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

For Technic Star Universal · 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 Shaker Teether Toy | Gel Filled Infant Teether; product code is 76 K - - KO Ring, Teething, Fluid-Filled | 76 K - - KO Ring, Teething, Fluid-Filled; date published is 01/23/2019; address is Limited Room 1013 Hung To Road , Road No. 1 Kwun Tong , Kowloon, HONG KONG SAR, verified against its source on 2026-09-16.

- **Firm:** Technic Star Universal _(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:** Limited Room 1013 Hung To Road , Road No. 1 Kwun Tong , Kowloon, HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 01/23/2019 _(verified: appears in the quote below)_
- **Product code:** 76 K - - KO Ring, Teething, Fluid-Filled | 76 K - - KO Ring, Teething, Fluid-Filled _(verified: each item appears in the quote below)_
- **Product:** Shaker Teether Toy | Gel Filled Infant Teether _(verified: each item appears in the quote below)_
- **FDA notes:** Class II; 10/5/2009 | Class II; 10/5/2009 _(verified: each item appears in the quote below)_

## What the source says

> Technic Star Universal Date Published : 01/23/2019 Limited Room 1013 Hung To Road , Road No. 1 Kwun Tong , Kowloon, HONG KONG SAR 76 K - - KO Ring, Teething, Fluid-Filled Date Published: 01/23/2019 Desc: Shaker Teether Toy Notes: Class II; 10/5/2009 76 K - - KO Ring, Teething, Fluid-Filled Date Published: 01/23/2019 Desc: Gel Filled Infant Teether Notes: Class II; 10/5/2009

## 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/).