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Polyganics B.V.,

NetherlandsFDA applicant, unverified

Devices
9

What Polyganics B.V., makes

Polyganics B.V. manufactures absorbable and non-absorbable medical devices for wound care and nerve repair, including nasal dressings (e.g., NASOPORE EAR and NASOPORE NASAL DRESSING), nerve guidance tubes (e.g., NEUROLAC NERVE GUIDE), and absorbable sheets (e.g., VIVOSORB SHEET). Their portfolio also includes hemostatic products like HEMOPORE and specialized dressings such as NASOPORE-FD.

The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for use in the US and follow applicable medical device regulations.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

  • Nasopore Ear Ref K070715 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivosorb Sheet, Model FS01 Ref K042811

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Nasopore Ear, Models ND04, ND05 Ref K062540

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 Ref K032115

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hemopore Ref K141816

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Neurolac Nerve Guide Ref K050573

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Neurolac(R) Nerve Guide Ref K112267

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Nasopore Nasal Dressing, Model Ndox-Yyy/Zz Ref K052099

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Nasopore-Fd Ref K141423

    Active Regimes: 510(k) Registry: 510(k) Class:I

Frequently asked questions

How many devices does Polyganics B.V., have in the registry?

The registry currently lists 9 devices for Polyganics B.V.,. Devices recorded under merged duplicate company entries are counted once.

Which registries list Polyganics B.V.,'s devices?

Among its 9 most recently registered devices, Polyganics B.V., has devices listed in FDA 510(k) (9 devices).

What risk classes do Polyganics B.V.,'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Polyganics B.V.,'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Polyganics B.V., in the registry?

The most recently registered devices listed for Polyganics B.V., include NASOPORE EAR, VIVOSORB SHEET, MODEL FS01, NASOPORE EAR, MODELS ND04, ND05 and NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03.

Generated automatically from registry data and not verified by a human reviewer.