Is this your brand? Sign in to claim ownership.

Oticon Medical AB

Sweden·SE-MF-000000724

Last updated September 17, 2026

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 1 of 3

Device	Model / Reference	Registries	Class	Status
Soft band, bilateral, Black	M50736	EUDAMEDFDA UDI	Class I	Active
Ponto 4, STG	186780	EUDAMEDFDA UDI	Class IIa	Active
Ponto 5 Mini, STG	223159	EUDAMEDFDA UDI	Class IIa	Active
Softband 5, Unilateral M/L Light Blue	267634	EUDAMEDFDA UDI	Class I	Active
Soft band, Black	M50637	EUDAMEDFDA UDI	Class I	Active
Soft band, Pink	M50551	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, bilateral, navy	185317	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, bilateral, turquoise	185320	EUDAMEDFDA UDI	Class I	Active
Genie Medical Bahs, Sales Pack 2024.2 Usb Uk	275203	EUDAMEDFDA UDI	Class IIa	Active
Sales Pack, Genie Medical Bahs 2023.1 Usb	254434	EUDAMEDFDA UDI	Class IIa	Active
Genie Medical BAHS, Sales Pack 2021.2 USB UK	226479	EUDAMEDFDA UDI	Class IIa	Active
Ponto 5 Mini, SIL	223155	EUDAMEDFDA UDI	Class IIa	Active
Flex Link Genie Medical Bahs 24.2	275351	EUDAMEDFDA UDI	Class IIa	Active
Screwdriver HexaDrive	265497	EUDAMEDFDA UDI	Class I	Active
Soft band, bilateral, Red	M50739	EUDAMEDFDA UDI	Class I	Active
Soft band, Beige	M50638	EUDAMEDFDA UDI	Class I	Active
Softband 5, Unilateral XS/S Light Brown	227692	EUDAMEDFDA UDI	Class I	Active
Iso File, Genie Medical Bahs 2023.1 Us Va	256950	EUDAMEDFDA UDI	Class IIa	Active
Softband 5, Bilateral XS/S Dark Brown	227703	EUDAMEDFDA UDI	Class I	Active
Ponto 4, TC	186778	EUDAMEDFDA UDI	Class IIa	Active
Softband 5, Bilateral XS/S Light Brown	227704	EUDAMEDFDA UDI	Class I	Active
Ponto 4, Demo, TC	201386	EUDAMEDFDA UDI	Class IIa	Active
Ponto 5 Mini DEMO, Diamond Black	227042	EUDAMEDFDA UDI	Class IIa	Active
Softband 5, Bilateral M/L Light Blue	267638	EUDAMEDFDA UDI	Class I	Active
Test band	M50104	EUDAMEDFDA UDI	Class I	Active
Softband 5, Bilateral M/L Beige	227701	EUDAMEDFDA UDI	Class I	Active
Softband 5, Bilateral M/L Navy Blue	267640	EUDAMEDFDA UDI	Class I	Active
Iso File, Genie Medical Bahs 2022.1 Uk	235655	EUDAMED	Class IIa	Active
Ponto Soft band, bilateral, pink	185314	EUDAMEDFDA UDI	Class I	Active
Ponto Bone Anchored Hearing System	K121228	FDA 510(k)	Class II	Active
Ponto Bone Anchored Hearing System	K152820	FDA 510(k)	Class II	Active
Ponto bone anchored hearing system	K152067	FDA 510(k)	Class II	Active
Obc Bone Anchored Hearing Aid System	K082108	FDA 510(k)	Class II	Active
Obc Bone Anchored Hearing System	K112053	FDA 510(k)	Class II	Active
Ponto Pro Power	K103594	FDA 510(k)	Class II	Active
Ponto Pro	K090996	FDA 510(k)	Class II	Active
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm	K142678	FDA 510(k)	Class II	Active
Ponto Plus And Ponto Plus Power	K132775	FDA 510(k)	Class II	Active
Ponto Bone Anchored Hearing System, MONO Surgery Kit	K203807	FDA 510(k)	Class II	Active
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower	K161671	FDA 510(k)	Class II	Active
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS	K240614	FDA 510(k)	Class II	Active
Softband 5, Bilateral M/L Pink	267639	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, pink	173369	EUDAMEDFDA UDI	Class I	Active
Ponto 4, DBL	186782	EUDAMEDFDA UDI	Class IIa	Active
Ponto 5 SuperPower, CNB	223164	EUDAMEDFDA UDI	Class IIa	Active
Softband 5, Unilateral XS/S Pink	227695	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, bilateral, green	185321	EUDAMEDFDA UDI	Class I	Active
Screwdriver hexagon	M50534	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, bilateral, grey	185322	EUDAMEDFDA UDI	Class I	Active
Ponto Soft band, beige	173366	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