Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005053770

FEI Number

3005053770

Entity Name

FIM MEDICAL

City/State/Country

Villeurbanne Cedex Rhone, FR

Establishment Address

51 Rue PRIMAT, CS 60194, Villeurbanne Cedex Rhone 69625, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FIM MEDICAL (Owner Number: 9045096)

Owner / Operator Contact Address

51 Rue PRIMAT, 69100, Villeurbanne Cedex, FR-69 69625, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161676

PMA Number

N/A

All Registered Proprietary Names

DMV Edition DEPISTEO VISION TESTER VISIOLITE VisioClick VT1 FF-1086 Face Cover Visiolite Access Audiolyser ADL Connect Earpad covers Audiolyser ADL-20 TABATABA Q13 Single-use Nose Clip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2008-09-09
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2009-01-20
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Anesthesiology	Class 2	868.1430	2008-12-04
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2016-10-21

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

FIM MEDICAL

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
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005053770. Last updated year: 2026. Please use registration number 3005053770 when referencing this establishment in official correspondence.