Data / Medical devices / Switzerland / Pentapharm AG
Pentapharm AG: FDA-registered device maker in Aesch Basel-Landschaft, Switzerland, 2 510(k) clearances
Pentapharm AG is registered with the FDA (registration 1000340866) in Aesch Basel-Landschaft, Switzerland. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 22, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000340866
- Address
- Dornacherstr. 112, Aesch Basel-Landschaft, Switzerland, 4147
- Owner or operator
- Pentapharm AG (9083272)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 22, 2006
- Registered through
- 2026
- Brand names listed
- PEFAKIT APC-R Factor V Leiden, PEFAKIT APC-R Factor V Leiden Controls
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Plasma, Abnormal | GGC | 2 | Contract manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Control | GGN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Plasma, Control, Normal | GIZ | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | 2 | Contract manufacturer | accessdata.fda.gov |
| Test, Time, Partial Thromboplastin | GGW | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 22, 2004 | K042762 | PEFAKIT APC-R FACTOR V LEIDEN | GGW | Substantially Equivalent | Pentapharm , Ltd. | accessdata.fda.gov |
| December 22, 2004 | K042760 | PEFAKIT APC-R FACTOR V LEIDEN CONTROLS | GGN | Substantially Equivalent | Pentapharm , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Plasma, Control, Normal
- All makers of System, Multipurpose For In Vitro Coagulation Studies
- All makers of Control, Plasma, Abnormal
- All makers of Test, Time, Partial Thromboplastin
- All makers of Plasma, Coagulation Control
Updated December 22, 2004. 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.