Teoxane S.A. · 89-08 · SWITZERLAND
For Teoxane S.A. · 89-08 · SWITZERLAND, 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 SWITZERLAND; product is TEOSYAL PureSense Deep Lines | TEOSYAL PureSense Ultra Deep | TEOSYAL PureSense Global Action; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use; date published is 03/08/2013; address is Rue De Lyon 105 , Geneva, Geneva SWITZERLAND, verified against its source on 2026-09-16.
- Firm
- Teoxane S.A. 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
- SWITZERLAND verified
- Address
- Rue De Lyon 105 , Geneva, Geneva SWITZERLAND verified
- Date published
- 03/08/2013 verified
- Product code
- 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use each item verified
- Product
- TEOSYAL PureSense Deep Lines | TEOSYAL PureSense Ultra Deep | TEOSYAL PureSense Global Action each item verified
- FDA notes
- class II; | class II; | class II; each item verified
What the source says
Teoxane S.A. Date Published : 03/08/2013 Rue De Lyon 105 , Geneva, Geneva SWITZERLAND 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/10/2021 Desc: TEOSYAL PureSense Deep Lines Notes: class II; 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/10/2021 Desc: TEOSYAL PureSense Ultra Deep Notes: class II; 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/10/2021 Desc: TEOSYAL PureSense Global Action Notes: class II;
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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