Brain Products Gmb · 89-08 · GERMANY
For Brain Products Gmb, 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 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 2026-09-30.
- 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
What the source says
Brain Products Gmb Date Published : 12/17/2010 Zeppelinstr. 7 , Gilching, Bavaria 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html