Cgb Alpheratz · 89-08 · FRANCE
For Cgb Alpheratz, import alert is 89-08; country is FRANCE; 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 DualChroma/Chromapuncteur-10 | DualChroma/Chromapuncteur-10; product code is 79 O - - NE Powered light based non-laser surgical instrument | 89 I - - SA Massager, Therapeutic, Electric; date published is 04/27/2018; address is 21 Des Tourrades , Mandelieu, FRANCE, verified against its source on 2026-09-30.
- Firm
- Cgb Alpheratz 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
- FRANCE verified
- Address
- 21 Des Tourrades , Mandelieu, FRANCE verified
- Date published
- 04/27/2018 verified
- Product code
- 79 O - - NE Powered light based non-laser surgical instrument | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- DualChroma/Chromapuncteur-10 | DualChroma/Chromapuncteur-10 each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Cgb Alpheratz Date Published : 04/27/2018 21 Des Tourrades , Mandelieu, FRANCE
— 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
79 O - - NE Powered light based non-laser surgical instrument Date Published: 04/27/2018 Desc: DualChroma/Chromapuncteur-10 Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/27/2018 Desc: DualChroma/Chromapuncteur-10 Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html