Data / Medical devices / France / Acp
Acp: FDA-registered device maker in MONTREUIL-BELLAY Maine-et-Loire, France, 2 510(k) clearances
Acp is registered with the FDA (registration 3003231640) in MONTREUIL-BELLAY Maine-et-Loire, France. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 7, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003231640
- Address
- Zone Industrielle de L Europe, MONTREUIL-BELLAY Maine-et-Loire, France, 49260
- Owner or operator
- SASMAR, INC. (10045183)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- October 25, 2013
- Registered through
- 2026
- Brand names listed
- Conceive Plus, SASMAR PERSONAL LUBRICANT, SASMAR® BASIC, SASMAR® CHERRY, SASMAR® CLASSIC, SASMAR® MELON, SASMAR® ORIGINAL, SASMAR® PINA COLADA and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | PEB | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 7, 2013 | K131355 | CONCEIVE PLUS | PEB | Substantially Equivalent | Sasmar, Inc. | accessdata.fda.gov |
| September 13, 2013 | K131084 | SASMAR ORIGINAL, SASMAR CLASSIC | NUC | Substantially Equivalent | Sasmar, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lubricant, Personal
- All makers of Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Updated November 7, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.