Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019907057

FEI Number

3019907057

Entity Name

INFIPLAST

City/State/Country

OYONNAX Ain, FR

Establishment Address

ZI OUEST II - BP14, 225 RUE DES COMBALETTES, OYONNAX Ain 01100, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

INFIPLAST (Owner Number: 10082105)

Owner / Operator Contact Address

ZI OUEST II - BP14, 225 RUE DES COMBALETTES, OYONNAX, FR-01 01100, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FILTRAY 2G Disposable Water Filters

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2021-07-08
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2025-12-08

Official Correspondent

CATHERINE SANDOZ

US Agent Details

Marilyne Joly Business: LOK USA, Inc. Email: regulatory@lok-northamerica.com Phone: (412) 2851076

Related Public Records

Same Entity

INFIPLAST

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019907057. Last updated year: 2026. Please use registration number 3019907057 when referencing this establishment in official correspondence.