Data / Medical devices / Malta / Sasmar Pharma Ltd
Sasmar Pharma Ltd: FDA-registered device maker in Ta' Xbiex, Malta, 2 510(k) clearances
Sasmar Pharma Ltd is registered with the FDA (registration 3040301765) in Ta' Xbiex, Malta. 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
- 3040301765
- Address
- 25, Villa Eden Triq Il-Principessa Elizabetta, Ta' Xbiex, Malta, XBX 1103
- Owner or operator
- SASMAR, INC. (10045183)
- Roles
- Complaint file establishment, Specification developer
- 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 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | PEB | 2 | Complaint file establishment, Specification developer | 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.