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Labomar S.p.A.

Italy·IT-MF-000007965

Last updated September 17, 2026

About

Project partner: Agripharma, Cereal Docks, Coccitech, Industria Casearia Silvio Belladelli, Labomar, Landlab, Latteria Di Soligo, Voltan, Università degli Studi di Padova, Università degli Studi di Verona, Università Cà Foscari di Venezia, Consiglio Nazionale delle Ricerche.

Translated from the manufacturer's own website. Source

What Labomar S.p.A. makes

Labomar S.p.A. manufactures oral and topical pharmaceutical formulations, including throat lozenges, syrups for cough and sore throat, and vaginal gels. Their portfolio also includes pediatric cough syrups, herbal-based respiratory remedies, and natural throat sprays, primarily targeting symptomatic relief of respiratory and gastrointestinal conditions.

The company’s products are classified under EU medical device regulations as Class I, IIa, IIb, and III, with all devices registered in the EUDAMED database. Labomar S.p.A. is based in Italy and adheres to European Union medical device compliance requirements.

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

Frequently asked questions

What types of medical devices does Labomar S.p.A. manufacture?

Labomar S.p.A. specializes in oral and topical pharmaceutical formulations designed for symptomatic relief. Their portfolio includes throat lozenges, syrups for cough and sore throat (such as pediatric formulations), herbal-based respiratory remedies, natural throat sprays, and vaginal gels. These devices are primarily intended to address respiratory and gastrointestinal discomfort.

Where is Labomar S.p.A. based, and what regulatory framework does it follow?

Labomar S.p.A. is based in Italy and operates under the European Union’s medical device regulations. Since their products fall under EU medical device classifications (Class I, IIa, IIb, and III), they must comply with EUDAMED registration requirements and other applicable EU regulatory standards.

Which regulatory databases list Labomar S.p.A.’s medical devices?

Labomar S.p.A.’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This ensures transparency and traceability of their products under EU medical device regulations.

How are Labomar S.p.A.’s devices classified under EU medical device regulations?

Labomar S.p.A.’s devices are classified into Class I, IIa, IIb, and III under the EU Medical Device Regulation (MDR). Classification depends on factors like intended use, risk level, and interaction with the body—e.g., throat lozenges (typically Class I) and certain vaginal gels (potentially Class IIb or III due to higher risk). Classification determines regulatory requirements like conformity assessment procedures.

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

Information

Country: Italy
Address: 35 I, Nazario Sauro, Istrana, Italy
Website: www.labomar.com
LinkedIn: linkedin.com/company/labomarspa
Facebook: facebook.com/labomarspa
Email: [email protected]
Phone: +3904227312
PRRC Contact: Davide Nenzioni
EUDAMED SRN: IT-MF-000007965
FDA FEI Number: —
DUNS Number: —

Catalogue (264)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
Sinulan Broncho Forte 120 ml BG	FTPR44	EUDAMED	Class IIa	Active
CICA-HEAL GEL 20 ml IQ	FTP042	EUDAMED	Class IIa	Active
SELEVITY BENETUSS ADULTI 150 mL IT	FTPR39	EUDAMED	Class IIa	Active
Juanola Tos Comprimidos Para Chupar Es	FTP087	EUDAMED	Class IIa	Active
NeoBorocillina gola Junior pastiglie gommose IT	FTP056	EUDAMED	Class IIa	Active
Silaut 30 ml VN	FTP021	EUDAMED	Class IIa	Active
Zantogin 30 ml IT	FTP009	EUDAMED	Class IIa	Active
Tantum Verde SOS Tosse 2 em 1 Crianças 150 mL PT	FTPR16	EUDAMED	Class IIa	Active
Silmed 30 ml PL	FTP021	EUDAMED	Class IIa	Active
TussControl Pediatric 20 ml IT	FTPR44	EUDAMED	Class IIa	Active
Propalnatur tos y dolor de garganta jarabe 10 ml stickpacks ES	FTP080	EUDAMED	Class IIa	Active
FERVEX PHYTO gardło i kaszel (FERVEX PHYTO Sore throat) PL	FTP087	EUDAMED	Class IIa	Active
Menocomplex gel vaginale 10 ml IT	FTP043	EUDAMED	Class IIa	Active
Biochetasi Reflusso 20 stick pack IT	FTP057	EUDAMED	Class III	Active
Silaut 30 ml BG, RO, RS	FTP021	EUDAMED	Class IIa	Active
Pavigin cremagel vaginale 10 ml IT	FTP021	EUDAMED	Class IIa	Active
Almora PLUS Normobowell GR, UAE	FTP054	EUDAMED	Class IIb	Active
Dicotuss baby med 100 mL IT	FTPR08	EUDAMED	Class IIa	Active
Almora PLUS REFLUX NO BURN GR, UAE	FTP058	EUDAMED	Class IIb	Active
Dicotuss baby med 20 mL PL	FTPR08	EUDAMED	Class IIa	Active
Bisolvon Tosse Complete 100 ml IT	FTPR65	EUDAMED	Class IIa	Active
GRANIONS® TOUX SECHE ET GRASSE 120 ml FR	FTP9394	EUDAMED	Class IIa	Active
Apteq Mielikki Limaa irrottava yskähunaja 120 ml FI	FTPR44	EUDAMED	Class IIa	Active
Quixx Cold Öksürük Şurubu 20 mL TR	FTPR25	EUDAMED	Class IIa	Active
lvex (Hustensaft) 100 mL AT	FTPR16	EUDAMED	Class IIa	Active
Apropos Sedituss Spray Adulti E Bambini It	FTPR12	EUDAMED	Class IIa	Active
Bisolvon Phyto Complete sugar free 100 ml CH	FTPR65	EUDAMED	Class IIa	Active
Dicospray Junior Pl	FTP012	EUDAMED	Class IIa	Active
TussControl Pediatric 150 ml FR	FTPR44	EUDAMED	Class IIa	Active
URGO Aftas Junior Gel 8 ml ES, PT	FTP040	EUDAMED	Class IIa	Active
Pastiglie Gola.lafarmacia. It	FTP022	EUDAMED	Class IIa	Active
lvex (Hustensaft) 200 mL AT	FTPR16	EUDAMED	Class IIa	Active
PHYTOVEX 120 ml ZA	FTP080	EUDAMED	Class IIa	Active
XAROPE PARA A TOSSE WELLS® 120 mL PT	FTPR44	EUDAMED	Class IIa	Active
Gastral Protect Srb	FTP058	EUDAMED	Class IIb	Active
Bei Reizdarm DE, AU	FTP054	EUDAMED	Class IIb	Active
Procto-Zac Relief Pl	FTP048	EUDAMED	Class IIb	Active
FERVEX PHYTO kaszel i gardło (FERVEX PHYTO Mixed Cough) 120 ml PL	FTP080	EUDAMED	Class IIa	Active
Hydrożelowy żel na rany 20 ml PL	FTP042	EUDAMED	Class IIa	Active
Actirub Maux De Gorge Fr	FTP088	EUDAMED	Class IIa	Active
Bisolvon Alle hoest voor volwassenen en kinderen suikervrij 100 ml NL	FTPR65	EUDAMED	Class IIa	Active
Selevity Benetuss sciroppo 150 mL IT	FTPR24	EUDAMED	Class IIa	Active
Bisolnatural 3 in1 sans sucre /Zonder suiker / ohne Zucker 100 ml BE	FTPR65	EUDAMED	Class IIa	Active
Sciroppo Tosse. 150 mL IT	FTPR44	EUDAMED	Class IIa	Active
Doppelherz aktiv Iritacolin RO	FTP054	EUDAMED	Class IIb	Active
SIROP TOUX IRRITATIVE 120 ml FR	FTP9394	EUDAMED	Class IIa	Active
Helenvita Cold & Flu Cough Syrup Kids 120 ml GR	FTP084	EUDAMED	Class IIa	Active
TussControl Pediatric 150 ml ES	FTPR44	EUDAMED	Class IIa	Active
Fluicare sciroppo 150 ml IT	FTP025	EUDAMED	Class IIa	Active
SIROP TOUX ET GORGE 120 ml FR	FTP084	EUDAMED	Class IIa	Active

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