Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022140316

FEI Number

3022140316

Entity Name

Polyganics Holding BV

City/State/Country

Groningen, NL

Establishment Address

Blauwborgje 32, Groningen 9747AC, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

POLYGANICS HOLDING BV (Owner Number: 9057333)

Owner / Operator Contact Address

Blauwborgje 32, --, GRONINGEN, NL-GR 9747 AC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152684

PMA Number

N/A

All Registered Proprietary Names

Neurolac-TW Vivosorb Nasopore Otopore NEUROLAC Nasopore FD Neurocap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2012-05-10
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2007-11-14
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2006-03-17
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2007-05-31
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2007-11-19
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2014-08-25
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2016-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

Peggy Hansen Email: phansen@collagenmatrix.com Phone: (201) 4051477

Related Public Records

Same Entity

POLYGANICS HOLDING BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022140316. Last updated year: 2026. Please use registration number 3022140316 when referencing this establishment in official correspondence.