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Spes Medica S.p.A.

Italy·IT-MF-000008858

Last updated September 17, 2026

What Spes Medica S.p.A. makes

Spes Medica S.p.A. manufactures electrocardiographic electrodes and accessories, including single-use ECG electrodes, subdermal needle electrodes, monopolar needle electrodes, hypodermic needle electrodes, and EEG headcaps, as well as reusable device sterilization/disinfection containers.

The company's products are classified as Class I and Class IIa medical devices and are listed in the EUDAMED database. Spes Medica S.p.A. is based in Italy.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Spes Medica S.p.A. manufacture?

Spes Medica S.p.A. manufactures electrocardiographic electrodes and accessories, including single-use ECG electrodes, subdermal needle electrodes, monopolar needle electrodes, hypodermic needle electrodes, EEG headcaps, and reusable device sterilization/disinfection containers.

Where is Spes Medica S.p.A. based?

Spes Medica S.p.A. is based in Italy, as indicated by the country code IT in the device data.

Which regulatory registries list Spes Medica S.p.A.'s devices?

Spes Medica S.p.A.'s devices are listed in the EUDAMED database, which is the European Union's medical device database.

How are Spes Medica S.p.A.'s devices classified?

Spes Medica S.p.A.'s devices are classified as Class I and Class IIa medical devices, with Class I being lower risk and Class IIa being moderate risk devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Italy
Address: 7, via degli Artigiani, Medolla, Italy
Website: www.medica-spa.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +39 0535 51159
PRRC Contact: ANTONIO ROSSETTI
EUDAMED SRN: IT-MF-000008858
FDA FEI Number: 3005581220
DUNS Number: —

Catalogue (556)

Page 2 of 12

Device	Model / Reference	Registries	Class	Status
Catetere 2CYS-9 / 2CYS-9 Catheter	2CYS-9	EUDAMED	Class IIa	Active
Accessorio fascette / Belt accessory	M03260	EUDAMED	Class IIa	Active
Spinfluxtm 15 Pur Hf	SPINFLUXTM 15 PUR HF	EUDAMED	Class IIb	Active
ECG Electrodes and accessories	LEAD202644	EUDAMED	Class I	Active
FractioPlas®19	M90358M	EUDAMED	Class IIb	Active
FractioPlas® 10	M90415M	EUDAMED	Class IIb	Active
Catetere manometria anorettale 12 canali con pallone / Anorectal manometry catheter with radial 12 channels with balloon	13R-14-100	EUDAMED	Class IIa	Active
0 Catetere manometria anorettale 4 canali elicoidali a 0.5 cm, 4 radiali e pallone a -1 cm / Anorectal manometry catheter with 4 helicoidal channels at 0.5 cm, 4 radial and balloon at -1 cm	9R-12-100	EUDAMED	Class IIa	Active
Hph-1400 Hemoconcentrator	93024-122	EUDAMED	Class IIb	Active
Smartflux L1.6	M03331	EUDAMED	Class IIb	Active
Catetere MMS G-88487 - 12 Fr. / MMS G-88487 catheter - 12 Fr.	S15668	EUDAMED	Class IIa	Active
Catetere MMS G-84481 - 12 Fr. / MMS G-84481 catheter - 12 Fr.	S15662	EUDAMED	Class IIa	Active
Catetere MMS G-88402 - 12 Fr. / MMS G-88402 catheter - 12 Fr.	S15658	EUDAMED	Class IIa	Active
Smartflux LFP.220 PUREMA	M03536	EUDAMED	Class IIb	Active
Hph Junior	93024-256	EUDAMED	Class IIb	Active
Emoconcentratore DP03HC - EO / DP03HC - EO Hemoconcentrator	M03957	EUDAMED	Class IIb	Active
Emoconcentratore DP15HC - EO / DP15HC - EO Hemoconcentrator	M03961	EUDAMED	Class IIb	Active
Hemocor Hph Mini	93024-111	EUDAMED	Class IIb	Active
Catetere MMS G-88489 - 12 Fr. / MMS G-88489 catheter - 12 Fr.	S15670	EUDAMED	Class IIa	Active
Emoconcentratore DP120HC - EO / DP120HC - EO Hemoconcentrator	M03963	EUDAMED	Class IIb	Active
Catetere 9R-12-100CB / 9R-12-100CB Catheter	9R-12-100CB	EUDAMED	Class IIa	Active
Catetere manometria anorettale 8 canali radiali con pallone / Anorectal manometry catheter with radial 8 channels with balloon	9R-12-100VB1H	EUDAMED	Class IIa	Active
Catetere per manometria esofagea, 4 lumi a 1 cm da 0 cm e 4 a 5 cm / Esophageal catheter 8 channels, 4 at 1 cm from 0 and 4 at 5 cm	9E-12-100L	EUDAMED	Class IIa	Active
Catetere MMS G-84384 - 9 Fr. / MMS G-84384 catheter - 9 Fr.	S15665	EUDAMED	Class IIa	Active
Smartflux LFP.06 PUREMA- PEDIATRIC	M03689	EUDAMED	Class IIb	Active
Catetere manometria anorettale 8 canali radiali a 0 cm con pallone a -3 cm / Anorectal manometry catheter 8 radial channels at 0 cm and balloon at -3 cm	9R-12-100VB3	EUDAMED	Class IIa	Active
FRACTIOsmart™Large Rheo - 2.0	M90395	EUDAMED	Class IIb	Active
Emoconcentratore DP07HC - EO / DP07HC - EO Hemoconcentrator	M03958	EUDAMED	Class IIb	Active
Catetere manometria anorettale 4 canali radiali a 0 cm e palloncino a -1 cm / Anorectal manometry catheter 4 radial channels at 0 cm and balloon at -1 cm	5R-12-100	EUDAMED	Class IIa	Active
Catetere MMS G-88486 - 12 Fr. / MMS G-88486 catheter - 12 Fr.	S15667	EUDAMED	Class IIa	Active
Catetere 5R-12-100CB / 5R-12-100CB Catheter	5R-12-100CB	EUDAMED	Class IIa	Active
Catetere manometria anorettale 8 canali radiali a 0 cm con pallone a -5 cm / Anorectal manometry catheter 8 radial channels at 0 cm and balloon at -5 cm	9R-12-100VB5	EUDAMED	Class IIa	Active
SELECTIsmart L 2.0	M90358	EUDAMED	Class IIb	Active
FRACTIOsmart™Small 1.0	M90149	EUDAMED	Class IIb	Active
Spinfluxtm 12 Pur Lf	SPINFLUXTM 12 PUR LF	EUDAMED	Class IIb	Active
Catetere MMS G-84383 - 9 Fr. / MMS G-84383 catheter - 9 Fr	S15664	EUDAMED	Class IIa	Active
Smartflux LFP .120 PUREMA	M90097	EUDAMED	Class IIb	Active
Catetere manometria anorettale 4 canali radiali a 0 cm e pallone a -3 cm / Anorectal manometry catheter 4 radial canals at 0 cm and balloon at -3 cm	5R-12-100VB3H	EUDAMED	Class IIa	Active
Emoconcentratore DP190HC - EO / DP190HC - EO Hemoconcentrator	M03965	EUDAMED	Class IIb	Active
Catetere 5R-9-100CB	5R-9-100CB	EUDAMED	Class IIa	Active
Smartflux LFP.140 PUREMA	M03534	EUDAMED	Class IIb	Active
Catetere MMS G-84480 - 12 Fr. / MMS G-84480 catheter - 12 Fr.	S15661	EUDAMED	Class IIa	Active
Catetere manometria anorettale 4 canali elicoidali ad 1 cm e palloncino a -3 cm / Anorectal manometry catheter 4 helicoidal channels at 1 cm and balloon at -3 cm	5R-12-100L3	EUDAMED	Class IIa	Active
Smartflux LFP.180 PUREMA	M03535	EUDAMED	Class IIb	Active
Subdermal needle electrode	MNCS0615DT6	EUDAMEDFDA UDI	Class IIa	Active
Monopolar needle electrode	TFDN451831	EUDAMEDFDA UDI	Class IIa	Active
Subdermal needle electrode	TT04MN4018L/10	EUDAMED	Class IIa	Active
Hypodermic needle electrodes	MIOBOT5050	EUDAMEDFDA UDI	Class IIa	Active
Subdermal needle electrode	MN4018D152/2	EUDAMED	Class IIa	Active
EEG Headcap	CAMSOLIA20	EUDAMED	Class I	Active

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