Reference Source

Eidam Diagnostic Corp. · 89-08 · CANADA

For Eidam Diagnostic Corp., import alert is 89-08; country is CANADA; 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)"; 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 140-11120 Horseshoe Way , Richmond, British Columbia CANADA, verified against its source on 2026-09-30.

Firm
Eidam Diagnostic 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
140-11120 Horseshoe Way , Richmond, British Columbia 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 Diagnostic Corp. Date Published : 04/14/2014 140-11120 Horseshoe Way , Richmond, British Columbia CANADA

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

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code, Product and FDA notes

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

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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