DERMAROLLER GMBH · 89-08 · GERMANY
For DERMAROLLER 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 03/13/2013; address is Lindener Str. 15 , Wolfenbuttel, Lower Saxony GERMANY, verified against its source on 2026-09-30.
- Firm
- DERMAROLLER 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
- Lindener Str. 15 , Wolfenbuttel, Lower Saxony GERMANY verified
- Date published
- 03/13/2013 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
- All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III | All Devices;class I/II/III each item verified
What the source says
DERMAROLLER GMBH Date Published : 03/13/2013 Lindener Str. 15 , Wolfenbuttel, Lower Saxony 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: 03/13/2013 Notes: All Devices;class I/II/III 74 - - - -- Cardiovascular Date Published: 03/13/2013 Notes: All Devices;class I/II/III 76 - - - -- Dental Date Published: 03/13/2013 Notes: All Devices;class I/II/III 77 - - - -- Ear,Nose And Throat Date Published: 03/13/2013 Notes: All Devices;class I/II/III 78 - - - -- Gastroenterological & Urological Date Published: 03/13/2013 Notes: All Devices;class I/II/III 79 - - - -- General & Plastic Surgery Date Published: 03/13/2013 Notes: All Devices;class I/II/III 80 - - - -- General Hospital/Personal Use Date Published: 03/13/2013 Notes: All Devices;class I/II/III 84 - - - -- Neurological Date Published: 03/13/2013 Notes: All Devices;class I/II/III 85 - - - -- Obstetrical & Gynecological Date Published: 03/13/2013 Notes: All Devices;class I/II/III 86 - - - -- Ophthalmic Date Published: 03/13/2013 Notes: All Devices;class I/II/III 87 - - - -- Orthopedic Date Published: 03/13/2013 Notes: All Devices;class I/II/III 89 - - - -- Physical Medicine Date Published: 03/13/2013 Notes: All Devices;class I/II/III 90 - - - -- Radiology Date Published: 03/13/2013 Notes: All Devices;class I/II/III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html