Reference Source

Erxer Bt. · 89-08 · HUNGARY

For Erxer Bt., import alert is 89-08; country is HUNGARY; 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 code is 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat; date published is 09/16/2009; address is Napsugar utca 21 , Csomad, Pest HUNGARY, verified against its source on 2026-09-30.

Firm
Erxer Bt. 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
HUNGARY verified
Address
Napsugar utca 21 , Csomad, Pest HUNGARY verified
Date published
09/16/2009 verified
Product code
89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat verified
FDA notes
Pollogen Regan/Pollegen MJ 5/12/2009 Shipper for Pollegen Ltd. verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Erxer Bt. Date Published : 09/16/2009 Napsugar utca 21 , Csomad, Pest HUNGARY

— 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 and FDA notes

89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Date Published: 09/16/2009 Notes: Pollogen Regan/Pollegen MJ 5/12/2009 Shipper for Pollegen Ltd.

— all from 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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