Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614860

FEI Number

3004612204

Entity Name

MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A.

City/State/Country

ROMA, IT

Establishment Address

Viale Luigi Schiavonetti, 270, ROMA 00173, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MIR MEDICAL INTL. RESEARCH S.P.A. (Owner Number: 9034107)

Owner / Operator Contact Address

Viale Luigi Schiavonetti 270, --, ROMA, IT-62 00173, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smart One Cohero - cSpirometer Spirotel Smart One Oxi AsthmaTuner Spirobank Smart Spirobank Oxi Cohero - mSpirometer Spirobank II Spirobank II PLUS Spirobank II Light Minispir Spirolab III Spirolab PLUS Spirolab Minispir PLUS Spirolab PLUS ESI Minispir PLUS ESI Spirodoc Nuvoair FlowMIR Reusable Turbine Plus FlowMIR Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2018-11-16
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2014-01-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-01-10
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2023-12-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-12-18
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2007-12-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2007-12-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-11-16
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2012-11-16
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-12-02
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2011-12-02
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2024-01-25

Official Correspondent

Giulia Maiorana

US Agent Details

Danny Rodriguez Email: danny.r@spirometry.com Phone: (844) 4647872

Related Public Records

Same Entity

MIR MEDICAL INTL. RESEARCH S.P.A.

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
K050853	Card Guard Scientific Survival , Ltd.	PMP4 SPIROPRO	2005-05-04
K123945	Monaghan Medical Corp.	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3008505660	eResearchTechnology GmbH	Estenfeld Bavaria, DE
1000604079	VINCENT MEDICAL MANUFACTURING. CO., LTD.	KOWLOON, HK
1317346	MONAGHAN MEDICAL CORP.	Plattsburgh, NY, US
9612777	TRUDELL MEDICAL INTERNATIONAL	LONDON Ontario, CA
3017202422	Flexicare Lanka (Pvt) Ltd	Bandaragama Western, LK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614860. Last updated year: 2026. Please use registration number 9614860 when referencing this establishment in official correspondence.