Otosan Srl
Italy IT-MF-000017617 Last updated 21 Oct 2026
- Devices
- 13
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Otosan Nasal Wash Ref FT002
Otosan Spray per l'igiene dell'orecchio Ref FT005
Otosan Gola Gel Forte Ref FT008
Otosan Gola Spray Forte Ref FT009
Otosan Gocce Auricolari Naturali Ref FT007
Otosan Nasal Spray Forte Ref FT003
Otosan Fortuss Sciroppo Ref FT006
Otosan Cone For The Ear Care 6 Cones Ref FT001
Otosan Nasal Spray Baby Ref FT004
Otosan Ref 1000012161
Otosan Ref 1000016285
Otosan Ref 1000101128
Otosan Ref 1000011231
About
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What Otosan Srl makes
Otosan Srl manufactures nasal spray products, including a formulation specifically designed for infants, as well as multiple variants of a topical nasal treatment. These devices are intended for local application in the nasal cavity to address congestion or irritation.
The company’s products are classified under EU medical device regulations as Class I and Class IIa, with all devices registered in the EU’s eudamed database. Otosan Srl operates from Italy and adheres to EU regulatory requirements for these device categories.
Frequently asked questions
What types of medical devices does Otosan Srl manufacture?
Otosan Srl specializes in nasal spray devices. Their portfolio includes a nasal spray formulated specifically for infants, as well as multiple variants of a topical nasal treatment. These products are designed for local application in the nasal cavity to relieve congestion or irritation.
Where is Otosan Srl based?
Otosan Srl is based in Italy. The company operates from this location while developing and manufacturing its medical devices in compliance with EU regulatory standards.
Which regulatory registries list Otosan Srl’s devices?
Otosan Srl’s devices are registered in the eudamed database, which is the European Union’s centralised registry for medical devices. This ensures transparency and traceability of their products under EU medical device regulations.
How are Otosan Srl’s devices classified under EU regulations?
Otosan Srl’s devices fall under Class I and Class IIa classifications in the EU’s medical device regulatory framework. This classification is determined by factors like the intended use, risk level, and duration of application, with Class IIa indicating a moderate risk requiring additional scrutiny.
Information
- Country
- Italy
- Address
- 32, DEGLI SCAVI, Forlì, Italy
- Website
- www.otosan.com
- facebook.com/Otosansrl
- [email protected]
- Phone
- +39 0543 795379
- PRRC contact
- Elisa Gianardi
- EUDAMED SRN
- IT-MF-000017617