Is this your brand? Sign in to claim ownership.

APPLE INC.

United States·US-MF-000013709

Last updated September 17, 2026

Information

Country: United States
Address: One, Apple Park Way, Cupertino, United States
Website: www.apple.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1-650-787-9838
PRRC Contact: Anni Zhao
EUDAMED SRN: US-MF-000013709
FDA FEI Number: 3014343954
DUNS Number: 060704780

Catalogue (26)

Device	Model / Reference	Registries	Class	Status
Cycle Tracking 3.0	Feature Version 3.x	FDA UDI	U	Active
Digital Prism Correction Feature (DPCF)	Feature version 1.X	FDA UDI	Class I	Active
Cycle Tracking 3.0	Feature Version 3.x	FDA UDI	U	Active
Irregular Rhythm Notifications	Feature Version 1.x	FDA UDI	Class II	Active
ECG 2.0 App	Feature Version 2.x	FDA UDI	Class II	Active
Hearing Aid Feature 2.0 (HAF 2.0)	Feature version 2.X	FDA UDI	Class II	Active
Hearing Test Feature (HTF)	Feature version 1.X	FDA UDI	Class II	Active
Hypertension Notification Feature (HTNF)	K250507	FDA 510(k)	Class II	Active
Digital Prism Correction Feature (DPCF)	K242058	FDA 510(k)	Class I	Active
IRNF App	K212516	FDA 510(k)	Class II	Active
Hearing Aid Feature (HAF)	DEN230081	FDA 510(k)	Class II	Active
Medical Imaging Calibration Feature (MICF)	K253582	FDA 510(k)	Class I	Active
Sleep Apnea Notification Feature (SANF)	K240929	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Irregular Rhythm Notification Feature (IRNF)	K231173	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Digital Prism Correction Feature (DPCF)	K250143	FDA 510(k)	Class I	Active
Hypertension Notification Feature	1.X	EUDAMEDFDA UDI	Class IIa	Active
Irregular Rhythm Notification Feature	1.X	EUDAMEDFDA UDI	Class IIa	Active
ECG app	ECG app 2.X	EUDAMEDFDA UDI	Class IIa	Active
Cycle Tracking App	Cycle Tracking App 4.X	EUDAMEDFDA UDI	Class I	Active
ECG app	ECG app 1.X	EUDAMEDFDA UDI	Class IIa	Active
Atrial Fibrillation History Feature	Atrial Fibrillation History Feature V1.X	EUDAMEDFDA UDI	Class IIa	Active
Apple Hearing Test Feature	Hearing Test Feature 1.X	EUDAMEDFDA UDI	Class IIa	Active
Apple Hearing Aid Feature	Hearing Aid Feature 1.X	EUDAMEDFDA UDI	Class IIa	Active
Sleep Apnea Notification Feature	Sleep Apnea Notification Feature 1.X	EUDAMEDFDA UDI	Class IIa	Active
Irregular Rhythm Notification Feature	2.X	EUDAMEDFDA UDI	Class IIa	Active
Hearing Aid Feature (2.X)	2.X	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Apple Distribution International Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.