Is this your brand? Sign in to claim ownership.

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)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Ponto 5 SuperPower, SIL	223161	EUDAMEDFDA UDI	Class IIa	Active
Ponto Soft band, bilateral, brown	185323	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral XS/S Navy Blue	227696	EUDAMEDFDA UDI	Class I	Active
Ponto 5 Mini, CNB	223158	EUDAMEDFDA UDI	Class IIa	Active
Softband 5, Bilateral M/L Black	227698	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, brown	173387	EUDAMEDFDA UDI	Class I	Active
Genie Medical Bahs, Sales Pack 2022.1 Usb Uk	235639	EUDAMEDFDA UDI	Class IIa	Active
Ponto 5 Mini, DBL	223160	EUDAMEDFDA UDI	Class IIa	Active
Ponto 4, SIL	186779	EUDAMEDFDA UDI	Class IIa	Active
Sales Pack, Genie Medical Bahs 2023.1 Dvd	254436	EUDAMEDFDA UDI	Class IIa	Active
Instant HearBand, S	284645	EUDAMED	Class I	Active
Ponto 5 SuperPower DEMO, Diamond Black	227043	EUDAMEDFDA UDI	Class IIa	Active
Ponto Soft band, bilateral, indigo	185318	EUDAMEDFDA UDI	Class I	Active
MIPS Back-up kit, 3mm	192233	EUDAMEDFDA UDI	Class IIa	Active
Ponto Soft band, bilateral, beige	185311	EUDAMEDFDA UDI	Class I	Active
Softband 5, Bilateral XS/S Black	227702	EUDAMEDFDA UDI	Class I	Active
MIPS Surgery kit, 4mm	192232	EUDAMEDFDA UDI	Class IIa	Active
Softband 5, Bilateral XS/S Red	227709	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, navy	173381	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, turquoise	173384	EUDAMEDFDA UDI	Class I	Active
Instant HearBand, M	284646	EUDAMED	Class I	Active
Healing cap	M50821	EUDAMED	Class I	Active
Softband, connector pad set	226779	EUDAMED	Class I	Active
Ponto Soft band, red	173368	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, yellow	173367	EUDAMEDFDA UDI	Class I	Active
Softband 5, Bilateral XS/S Light Blue	227706	EUDAMEDFDA UDI	Class I	Active
Counter torque wrench	M51690	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral XS/S Black	227690	EUDAMEDFDA UDI	Class I	Active
Ruler	M52143	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral M/L Dark Brown	227687	EUDAMEDFDA UDI	Class I	Active
Soft band, Light blue	M50612	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, bilateral, black	185324	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral M/L Red	267637	EUDAMEDFDA UDI	Class I	Active
Soft band, bilateral, Light blue	M50735	EUDAMEDFDA UDI	Class I	Active
Wide countersink, 3mm	M51144	EUDAMEDFDA UDI	Class IIa	Active
Ponto 5 SuperPower, STG	223165	EUDAMEDFDA UDI	Class IIa	Active
Ponto 5 SuperPower, TC	223163	EUDAMEDFDA UDI	Class IIa	Active
Ponto Soft band, green	173385	EUDAMEDFDA UDI	Class I	Active
MONO Surgery Kit	220701	EUDAMEDFDA UDI	Class IIa	Active
Ponto Soft band, black	173388	EUDAMEDFDA UDI	Class I	Active
Ponto 5 SuperPower, CBE	223162	EUDAMEDFDA UDI	Class IIa	Active
Ponto Soft band, indigo	173382	EUDAMEDFDA UDI	Class I	Active
Ponto 5 Mini, CBE	223156	EUDAMEDFDA UDI	Class IIa	Active
Soft band, bilateral, Beige	M50737	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, grey	173386	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

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

Oticon Medical US