Manufacturer

FIAB

ItalyLegal entities : FIAB S.p.A.

Markets : Italy · United States

Approvals : EU – class I, IIb, III · United States (FDA) – 510(k) : 7 · class II · latest in 2019 · see on the FDA website

Public contracts won : Italy 60

Website quality@fiab.it

15 categories, 85 models including 85 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Neurologic physiotheraphy devices - other	N010299	Adhesive and conductive gel pads for electrostimulation3 refs Adhesive and conductive gel pads for electrostimulation PG271/353 refs Adhesive and conductive gel sheet for electrostimulation PG9072 refs Carbon electrodes Conductive galvanic silicone electrodes and bags for electro-stimulation 21 others Conductive gloves PG1040/L3 refs Conductive silicone electrodes for electro-stimulation Conductive silicone electrodes PG912/23 refs Conductive slippers2 refs Electrostimulatio set2 refs Fully gelled electrodes for bioimpedance analysis Fully gelled electrodes for neurostimulation6 refs Hydro compressed sponges3 refs Mask for electrostimulation PG1011 Reusable conductive bands in elasticized fabric3 refs Reusable conductive bracelets for electrostimulation3 refs Reusable conductive silicone bands PG9013 refs Reusable conductive silicone bands PG901/2/RU3 refs Reusable electrodes electrostimulation “easystim”6 refs Reusable electrodes for electrostimulation PG9043 refs Reusable electrodes for electrostimulation PG931/120/RU3 refs Reusable electrodes for electrostimulation “TOP PACE”3 refs Self-adhesive for electro stimulation and EMG3 refs Spontex electrodes holding bags6 refs Syntetic buckskin insole3 refs Synthetic buckskin electrodes holding bags3 refs	I MDR	EUDAMED record Report an error
Non-implantable cardiac stimulators - hardware accessories	Z12050680	Adapter cables F7830/ADTEK303 refs Adapter cables F7840/TEKBIO2 refs Adapters Adapters PG922/2TP103 refs Bipolar adapter cables 20 others Bipolar adapter cables F7818/30MED3 refs Bipolar extension cables3 refs Bipolar extension cables F7817/30LC3 refs Cavo special function per 2007 Connection cable for BIOTRONIK REOCOR S Connection cables for MEDTRONIC PROGRAMMER 20902 refs Monopolar extension cables for ECG F78353 refs Multipolar extension cables 4452Q Multipolar extension cables F5401TPS3 refs Multipolar extension cables F5416/4RED Multipolar extension cables F7818/4BIOLC Reausable bipolar extension cables3 refs Reusable bipolar extension cables 81828BL3 refs Reusable bipolar extension cables F7815/303 refs Reusable bipolar extension cables F7816S/303 refs Reusable multipolar extension cable F7817TP3/353 refs Threshold cable for cardiac stimulation3 refs Threshold cable for cardiac stimulation F7830/MED3 refs Threshold cable for cardiac stimulation FCB7830/TEKASB Threshold/connection cable for branch stimulation and/or alternative sites	I MDR	EUDAMED record Report an error
Electrocardiographs - hardware accessories	Z12050380	Adapter for connector cables for ECG and electrostumulation6 refs Connection cable F9022D/KIT33 refs Connection cable F9032DN/13 refs ECG patient cable - European Version6 refs ECG patient cable - USA Version6 refs	I MDR	EUDAMED record Report an error
Electrosurgery instruments - hardware accessories	Z12010980	Adapter for electrosurgery Adapter for electrosurgery F48263 refs Connecting cables between pads and electrosurgical unit3 refs Reusable cable for elettrosulgical bipolar forceps3 refs Reusable electrocautery2 refs	I, IIb MDR	EUDAMED record Report an error
Body temperature measuring devices - other	V030199	ESOTEST MULTI - Clinical programmable esophageal temperature monitor ESOTEST MULTI - Patient cable SENSITHERM MULTI - Patient cable SENSITHERM MULTI MONITOR - Clinical programmable esophageal temperature monitor	IIb MDR	EUDAMED record Report an error
Body temperature monitoring probes - other	V03010299	ESOTHERM MULTI - Esophageal temperature probe3 refs ESOTHERM PLUS - Esophageal temperature probe SENSITHERM MULTI PROBE - Esophageal temperature probe SENSITHERM PROBE - Esophageal temperature probe	IIb MDR	EUDAMED record Report an error
Invasive cardiac stimulators	Z12050602	Dual-chamber external cardiac stimulator Dual-chamber external cardiac stimulator 1797/N3 refs Single-chamber external cardiac stimulator 1748/N3 refs Single-chamber external cardiac stimulator 1749/N3 refs	III MDR	EUDAMED record Report an error
Diathermocoagulators	Z12010901	Disposable sterile electrocautery6 refs Tip for reusable electrocautery3 refs	IIb MDR	EUDAMED record Report an error
Electromyography instruments - hardware accessories	Z12100480	Connection cables for EEG and EMG F8959/13 refs Connection cables for EEG and EMG F8995/NI/RU	I MDR	EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - hardware accessories	Z129080	ESOTEST MULTI - Adapter cable3 refs SENSITHERM MULTI - Adapter cable3 refs	I MDR	EUDAMED record Report an error
Various physiotherapy and rehabilitation instruments - hardware accessories	Z12069080	Connecting cables4 refs Connecting cables between pads and electrosurgical unit3 refs	I MDR	EUDAMED record Report an error
Electroencephalography instruments - hardware accessories	Z12100380	Connection cables for EEG and EMG F5310D3 refs	I MDR	EUDAMED record Report an error
Neurological stimulators	Z12101106	Ring electrode F8903/13 refs	I MDR	EUDAMED record Report an error
Non-implantable cardiac stimulators - consumables	Z12050685	Disposable electrodes defibrillation, cardioversion, cardiac stimulator, ECG3 refs	IIb MDR	EUDAMED record Report an error
Various instruments for cardiology and cardiac surgery - hardware accessories	Z12059080	SENSITHERM - Connecting cable3 refs	I MDR	EUDAMED record Report an error

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