Reference Source

DERMAROLLER GMBH · 89-08 · GERMANY

For DERMAROLLER GMBH · 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 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

DERMAROLLER GMBH Date Published : 03/13/2013 Lindener Str. 15 , Wolfenbuttel, Lower Saxony GERMANY 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

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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