Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008699634

FEI Number

3008699634

Entity Name

INVENTIS SRL

City/State/Country

Padova, IT

Establishment Address

Corso Stati Uniti 1/3, Padova 35127, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Inventis srl (Owner Number: 10033997)

Owner / Operator Contact Address

Corso Stati Uniti 1/3, Padova, IT-PD 35127, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242726

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTO	Tester, Auditory Impedance, Exempt	Ear, Nose, Throat	Class 2	874.1090	2018-06-01
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2016-01-12
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2010-10-26
FWG	Camera, Television, Endoscopic, With Audio	General, Plastic Surgery	Class 1	878.4160	2010-10-26
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2012-01-25
GWN	Nystagmograph	Neurology	Class 2	882.1460	2025-01-07

Official Correspondent

Massimo Martinelli

US Agent Details

Lorenzo Da Madice Business: ISOPLAN USA Email: isoplan@fda-510k.com Phone: (386) 8680618

Related Public Records

Same Entity

Inventis srl

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
K010059	Western Systems Research, Inc.	ENGPLUS	2001-02-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008699634. Last updated year: 2026. Please use registration number 3008699634 when referencing this establishment in official correspondence.