Reference Source

Novafon Elektromedizinche Gerate Gmbh (aka Novafon Gmbh) · 89-08 · GERMANY

For Novafon Elektromedizinche Gerate Gmbh (aka Novafon Gmbh), import alert is 89-08; country is GERMANY; 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 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 09/16/2009; address is unknown , Stuttgart, GERMANY, verified against its source on 2026-09-30.

Firm
Novafon Elektromedizinche Gerate Gmbh (aka Novafon Gmbh) 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
GERMANY verified
Address
unknown , Stuttgart, GERMANY verified
Date published
09/16/2009 verified
Product code
73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology each item verified
FDA notes
DE = Nostrafon SK2 Sound Wave Appliance. Medi-Pol (magnetic field therapy used as an accessory device with Nostrafon Unit). verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Novafon Elektromedizinche Gerate Gmbh (aka Novafon Gmbh) Date Published : 09/16/2009 unknown , Stuttgart, GERMANY

— 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

73 - - - -- Anesthesiology Date Published: 09/16/2009 Notes: DE = Nostrafon SK2 Sound Wave Appliance. Medi-Pol (magnetic field therapy used as an accessory device with Nostrafon Unit). 74 - - - -- Cardiovascular Date Published: 09/16/2009 76 - - - -- Dental Date Published: 09/16/2009 77 - - - -- Ear,Nose And Throat Date Published: 09/16/2009 78 - - - -- Gastroenterological & Urological Date Published: 09/16/2009 79 - - - -- General & Plastic Surgery Date Published: 09/16/2009 80 - - - -- General Hospital/Personal Use Date Published: 09/16/2009 84 - - - -- Neurological Date Published: 09/16/2009 85 - - - -- Obstetrical & Gynecological Date Published: 09/16/2009 86 - - - -- Ophthalmic Date Published: 09/16/2009 87 - - - -- Orthopedic Date Published: 09/16/2009 89 - - - -- Physical Medicine Date Published: 09/16/2009 90 - - - -- Radiology Date Published: 09/16/2009

— 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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