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Oticon Medical AB

Sweden·SE-MF-000000724

Last updated September 17, 2026

What Oticon Medical AB makes

Oticon Medical AB manufactures bone anchored hearing systems, including the Ponto 4, Ponto 5 Mini, and various Softband models in different colors and configurations.

The company's portfolio includes Class I, Class II, and Class IIa devices, listed in both EUDAMED and FDA 510(k) registries, and is based in Sweden.

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

Frequently asked questions

What does Oticon Medical AB manufacture?

Oticon Medical AB manufactures bone anchored hearing systems, including the Ponto 4, Ponto 5 Mini, and various Softband models in different colors and configurations. They also produce open-surgery dissectors and sterilizer/disinfector racks.

Where is Oticon Medical AB based?

Oticon Medical AB is based in Sweden, as indicated by the country code SE in their device data.

Which regulatory registries list Oticon Medical AB's devices?

Oticon Medical AB's devices are listed in both EUDAMED and FDA 510(k) registries, as specified in their device data.

How are Oticon Medical AB's devices classified?

Oticon Medical AB's devices are classified as Class I, Class II, and Class IIa, with Class IIa being the most common classification among their products.

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

Information

Country: Sweden
Address: 37B, Datavägen, Askim, Sweden
Website: www.oticonmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 888-277-8014
PRRC Contact: Karolin Isberg Jernby
EUDAMED SRN: SE-MF-000000724
FDA FEI Number: 3007367732
DUNS Number: 554563994

Catalogue (145)

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Device	Model / Reference	Registries	Class	Status
Softband 5, Bilateral XS/S Navy Blue	227708	EUDAMEDFDA UDI	Class I	Active
Genie Medical Bahs, Sales Pack 2022.1 Dvd Uk	235649	EUDAMEDFDA UDI	Class IIa	Active
Screwdriver, machine, 35mm	M50384	EUDAMEDFDA UDI	Class IIa	Active
Square fit connection, machine	M50386	EUDAMEDFDA UDI	Class IIa	Active
Iso File, Genie Medical Bahs 2024.2 Uk	275208	EUDAMED	Class IIa	Active
Ponto SoundConnector	173391	EUDAMEDFDA UDI	Class I	Active
Soft band, Red	M50640	EUDAMEDFDA UDI	Class I	Active
Instant HearBand, L	284647	EUDAMED	Class I	Active
Softband 5, Unilateral XS/S Dark Brown	227691	EUDAMEDFDA UDI	Class I	Active
Softband 5, Bilateral M/L Dark Brown	227698	EUDAMEDFDA UDI	Class I	Active
Iso File, Genie Medical Bahs 2023.1 Uk	256948	EUDAMED	Class IIa	Active
Wide countersink, 4mm	M51122	EUDAMEDFDA UDI	Class IIa	Active
Ponto 4, CBE	186777	EUDAMEDFDA UDI	Class IIa	Active
Ponto Soft band, blue	173383	EUDAMEDFDA UDI	Class I	Active
Soft band, Navy blue	M50639	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral M/L Black	227686	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, bilateral, cerise	185315	EUDAMEDFDA UDI	Class I	Active
Softband 5, Bilateral XS/S Beige	227705	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, bilateral, purple	185316	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral M/L Navy Blue	267636	EUDAMEDFDA UDI	Class I	Active
Abutment inserter, machine	M51695	EUDAMEDFDA UDI	Class IIa	Active
Softband 5, Bilateral M/L Red	267641	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral M/L Pink	267635	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral XS/S Red	227697	EUDAMEDFDA UDI	Class I	Active
Softband 5, Bilateral M/L Light Brown	227700	EUDAMEDFDA UDI	Class I	Active
Sound processor indicator	M50428	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral M/L Light Brown	227688	EUDAMEDFDA UDI	Class I	Active
Iso File, Genie Medical Bahs 2024.2 Us Va	275209	EUDAMEDFDA UDI	Class IIa	Active
Ponto Soft band, bilateral, yellow	185312	EUDAMEDFDA UDI	Class I	Active
Head band	M50308	EUDAMEDFDA UDI	Class I	Active
Soft healing cap	M52080	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, cerise	173379	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, bilateral, red	185313	EUDAMEDFDA UDI	Class I	Active
Soft band, bilateral, Pink	M50734	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral XS/S Beige	227693	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, purple	173380	EUDAMEDFDA UDI	Class I	Active
Genie Medical BAHS, Sales Pack 2021.2 DVD UK	226483	EUDAMEDFDA UDI	Class IIa	Active
Softband 5, Unilateral M/L Beige	227689	EUDAMEDFDA UDI	Class I	Active
Guide drill, 3-4mm	M50287	EUDAMEDFDA UDI	Class IIa	Active
Ponto 4, CNB	186781	EUDAMEDFDA UDI	Class IIa	Active
Ponto Soft band, bilateral, blue	185319	EUDAMEDFDA UDI	Class I	Active
Ponto 5 SuperPower, DBL	223166	EUDAMEDFDA UDI	Class IIa	Active
Handle with screwdriver	M50437	EUDAMEDFDA UDI	Class IIa	Active
Soft band, bilateral, Navy blue	M50738	EUDAMEDFDA UDI	Class I	Active
Ponto 5 Mini, TC	223157	EUDAMEDFDA UDI	Class IIa	Active
Sterilization Cassette	M52074	EUDAMEDFDA UDI	Class I	Active
Softband 5, Bilateral XS/S Pink	227707	EUDAMEDFDA UDI	Class I	Active
Double-ended dissector	M52196	EUDAMEDFDA UDI	Class I	Active
Instant SoundConnector	284648	EUDAMED	Class I	Active
Softband 5, Unilateral XS/S Light Blue	227694	EUDAMEDFDA UDI	Class I	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Oticon Medical US