Reference Source

Brain Products Gmb · 89-08 · GERMANY

For Brain Products Gmb · 89-08 · GERMANY, 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 GERMANY; product is Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps; 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 12/17/2010; address is Zeppelinstr. 7 , Gilching, Bavaria GERMANY, verified against its source on 2026-09-16.

Firm
Brain Products Gmb 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
Zeppelinstr. 7 , Gilching, Bavaria GERMANY verified
Date published
12/17/2010 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
Product
Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps | Brain Amps each item verified
FDA notes
Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 | Class II 8/10/2026 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

Brain Products Gmb Date Published : 12/17/2010 Zeppelinstr. 7 , Gilching, Bavaria GERMANY 73 - - - -- Anesthesiology Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 74 - - - -- Cardiovascular Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 76 - - - -- Dental Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 77 - - - -- Ear,Nose And Throat Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 78 - - - -- Gastroenterological & Urological Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 79 - - - -- General & Plastic Surgery Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 80 - - - -- General Hospital/Personal Use Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 84 - - - -- Neurological Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 85 - - - -- Obstetrical & Gynecological Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 86 - - - -- Ophthalmic Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 87 - - - -- Orthopedic Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 89 - - - -- Physical Medicine Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026 90 - - - -- Radiology Date Published: 08/14/2026 Desc: Brain Amps Notes: Class II 8/10/2026

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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