FBI Medizintechnik GmbH

Importer

🇩🇪 Germany·1 Manufacturer

DiLo Medical

Authorized representative

🇫🇷 France·1 Manufacturer

PUFFClicker3 Inhaler Dose Counter Accessory for Spriomax DuoResp DPI

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Aseptika Limited·1 device

061-00-00-MDR

Certificate

MDR QMS·GPI S.P.A.·ITALCERT SRL

IT321284

Certificate

MDR QMS·GPI S.P.A.·BUREAU VERITAS ITALIA S.P.A.

IT321284

Certificate

MDR QMS·GPI S.P.A.·BUREAU VERITAS ITALIA S.P.A.

Cliniview

FDA 510(k)

FDA Class 2 ·Radiology

ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)

FDA 510(k)

FDA Class 2 ·Orthopedic

ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)

FDA 510(k)

FDA Class 2 ·Orthopedic

E-EEGX, N-EEGX

FDA 510(k)

FDA Class 2 ·Neurology

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE B450

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACTIVASCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE B450, E-musb

FDA 510(k)

FDA Class 2 ·Cardiovascular

Steriking® LT-Blueline Pouches with Tyvek®

FDA 510(k)

FDA Class 2 ·General Hospital

CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

FDA 510(k)

FDA Class 2 ·Anesthesiology

Icare ic100

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX

FDA 510(k)

FDA Class 2 ·Anesthesiology

Steriking LT-Blueline Pouches with Tyvek

FDA 510(k)

FDA Class 2 ·General Hospital

PLANMED NUANCE DIGIGUIDE

FDA 510(k)

FDA Class 2 ·Radiology