Data / Medical devices / Netherlands / Polyganics Holding BV
Polyganics Holding BV: FDA-registered device maker in Groningen, Netherlands, 4 510(k) clearances
Polyganics Holding BV is registered with the FDA (registration 3022140316) in Groningen, Netherlands. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 13, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022140316
- Address
- Blauwborgje 32, Groningen, Netherlands, 9747AC
- Owner or operator
- POLYGANICS HOLDING BV (9057333)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 17, 2006
- Registered through
- 2026
- Brand names listed
- Hemopore, NEUROLAC, Nasopore, Nasopore FD, Neurocap, Neurolac-TW, Otopore, Vivosorb
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cuff, Nerve | JXI | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | 2 | Contract manufacturer | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| January 13, 2016 | K152684 | Nerve Capping Device | JXI | Substantially Equivalent | Polyganics Innovations BV | accessdata.fda.gov |
| October 20, 2011 | K112267 | NEUROLAC(R) NERVE GUIDE | JXI | Substantially Equivalent | Polyganics B.V., | accessdata.fda.gov |
| May 4, 2005 | K050573 | NEUROLAC NERVE GUIDE | JXI | Substantially Equivalent | Polyganics B.V., | accessdata.fda.gov |
| November 8, 2004 | K042811 | VIVOSORB SHEET, MODEL FS01 | FTL | Substantially Equivalent | Polyganics B.V., | accessdata.fda.gov |
Compare with other makers
- All makers of Cuff, Nerve
- All makers of Splint, Intranasal Septal
- All makers of Mesh, Surgical, Polymeric
- All makers of Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Updated January 13, 2016. 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.