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Cycle Tracking App

by Apple Inc.

Ref Cycle Tracking App 4.X

Cycle Tracking App (Cycle Tracking App 4.X) is a device classified as Class I (EU), Unclassified (US) made by Apple Inc., registered in EUDAMED on 6 May 2026 (Basic UDI-DI 0194253CycleTracking44C) and listed in FDA GUDID since 1 Nov 2024 (UDI-DI 00194253312512), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0194253CycleTracking44C Basic UDI-DI Date6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00194253312512 UDI-DI Date1 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0194253CycleTracking44C registered 6 May 2026 Active
  • FDA GUDID UDI-DI 00194253312512 listed 1 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00194253312512
  2. Registered EUDAMED 0194253CycleTracking44C

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Cycle Tracking 4.0
Generic name
Menstrual cycle self-monitoring software
Device name
Cycle Tracking App
Model / reference
Cycle Tracking App 4.X EUDAMED
Feature Version 4.x GUDID
Primary DI / UDI-DI
00194253312512, 00194253312529
Basic UDI-DI
0194253CycleTracking44C
Direct marketing DI
00194253312512
00194253312529
FDA product code
LHD
EMDN code
Z12080282 Gynaecology and fertility treatment instruments - software accessories
GMDN term
Menstrual cycle self-monitoring software
Device class
Class I EUDAMED
U GUDID
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Cycle Tracking App 4.X
GUDID
Feature Version 4.x
Device classEUDAMED
Class I
GUDID
U

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000013709
Authorised representative
Apple Distribution International Limited IE-AR-000012406

Similar devices in this category

Other devices filed under GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS.

Other devices from Apple Inc.

See all devices from Apple Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)