Reference Source

Asia Unlimited · 89-08 · HONG KONG SAR

For Asia Unlimited · 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 code is 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); date published is 09/16/2009; address is Unknown , Hong Kong, HONG KONG SAR, verified against its source on 2026-09-16.

Firm
Asia Unlimited 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
Unknown , Hong Kong, HONG KONG SAR verified
Date published
09/16/2009 verified
Product code
86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) verified
FDA notes
The Shealy RelaxMate (aka RelaxEase) 8/27/1998 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Asia Unlimited Date Published : 09/16/2009 Unknown , Hong Kong, HONG KONG SAR 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) Date Published: 09/16/2009 Notes: The Shealy RelaxMate (aka RelaxEase) 8/27/1998

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

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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