Eidam Diagnostics Corp · 89-08 · CANADA
For Eidam Diagnostics 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 13777 Commerce Parkway Rm 101 , Richmond, BC CANADA, verified against its source on 2026-09-30.
- 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
What the source says
Eidam Diagnostics Corp Date Published : 04/14/2014 13777 Commerce Parkway Rm 101 , Richmond, BC 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
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html