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Apple Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000013709 FEI 3014343954

Apple Inc. is a medical device manufacturer based in the United States, with 30 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class IIa; FDA Class II, Class I and Unclassified) as of 13 Nov 2026.

Devices
30
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 22
  • EUDAMED 19
  • FDA 510(k) 8

A device listed in two registries counts in both.

Device classes
  • EU Class IIa 12
  • FDA Class II 9
  • FDA Class I 6
  • FDA Unclassified 2
  • EU Class I 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000013709
  • FDA FEI 3014343954
  • DUNS 060704780

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI
Authorised rep.
Apple Distribution International LimitedIE

Catalogue30

Newest first, rows 1-30 of 30

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Rows 1-30 of 30

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000013709
FDA FEI number
3014343954
DUNS number
060704780
EUDAMED status
Active
EUDAMED registered name
Apple Inc.
EUDAMED abbreviated name
Apple
Registered address
One, Apple Park Way, 95014, Cupertino, United States
Website
www.apple.com
Phone
+1-650-787-9838
PRRC contact
Anni Zhao(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 16 Jun 2027

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 082774 0025 Expiring Expires in 215 days

    Quality management system EU MDR

    Issued
    28 Aug 2024
    Expires
    16 Jun 2027

Frequently asked questions

How many devices does APPLE INC. have in the registry?

The registry currently lists 30 devices for APPLE INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list APPLE INC.'s devices?

Among its 30 most recently registered devices, APPLE INC. has devices listed in EUDAMED (19 devices), FDA 510(k) (8 devices) and FDA GUDID (22 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do APPLE INC.'s devices fall under?

Among its 30 most recently registered devices, the classes recorded for APPLE INC.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for APPLE INC.?

EUDAMED lists 1 certificate for APPLE INC. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 28 Aug 2024.

What are the newest devices from APPLE INC. in the registry?

The most recently registered devices listed for APPLE INC. include Hypertension Notification Feature, Medical Imaging Calibration Feature (MICF) Feature version 1.X, Cycle Tracking 3.0 Feature Version 3.x and Digital Prism Correction Feature (DPCF) Feature version 1.X.

Generated automatically from registry data and not verified by a human reviewer.