Reference Source

Eidam Diagnostics Corp · 89-08 · CANADA

For Eidam Diagnostics Corp · 89-08 · CANADA, 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 CANADA; product is CRT2000 Thermographic System | CRT2000 Thermographic System; product code is 85 L - - HQ System, Telethermographic (Adjunctive Use) | 90 L - - HQ System, telethermographic (adjunctive use); date published is 04/14/2014; address is 13777 Commerce Parkway Rm 101 , Richmond, BC CANADA, verified against its source on 2026-09-16.

Firm
Eidam Diagnostics Corp 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
CANADA verified
Address
13777 Commerce Parkway Rm 101 , Richmond, BC CANADA verified
Date published
04/14/2014 verified
Product code
85 L - - HQ System, Telethermographic (Adjunctive Use) | 90 L - - HQ System, telethermographic (adjunctive use) each item verified
Product
CRT2000 Thermographic System | CRT2000 Thermographic System each item verified
FDA notes
Class II | Class II each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Eidam Diagnostics Corp Date Published : 04/14/2014 13777 Commerce Parkway Rm 101 , Richmond, BC CANADA 85 L - - HQ System, Telethermographic (Adjunctive Use) Date Published: 04/14/2014 Desc: CRT2000 Thermographic System Notes: Class II 90 L - - HQ System, telethermographic (adjunctive use) Date Published: 07/24/2017 Desc: CRT2000 Thermographic System Notes: Class II

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

Source

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