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Cycle Tracking App
EUDAMEDFDA UDIClass I (EU MDR)
Ref Cycle Tracking App 4.X
by Apple Inc.
Identity
- Trade Name
- Cycle Tracking 4.0 FDA UDI
- Generic Name
- Menstrual cycle self-monitoring software FDA UDI
- Device Name
- Cycle Tracking App EUDAMEDCycle Tracking Watch App (Version 4.0) FDA UDICycle Tracking iPhone App (Version 4.0) FDA UDI
- Model / Reference
- Cycle Tracking App 4.X EUDAMEDFeature Version 4.x FDA UDI
- Description
- Cycle Tracking Watch App (Version 4.0) FDA UDICycle Tracking iPhone App (Version 4.0) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00194253312512 EUDAMEDFDA UDI00194253312529 EUDAMEDFDA UDI
- Basic UDI-DI
- 0194253CycleTracking44C EUDAMED
- Direct Marketing DI
- 00194253312512 EUDAMED00194253312529 EUDAMED
- FDA Product Code
- LHD FDA UDI
- EMDN Code
- Z12080282 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Menstrual cycle self-monitoring software FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cycle Tracking App by Apple Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0194253CycleTracking44C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Apple Inc.
- EUDAMED SRN
- US-MF-000013709
- Authorised Representative
- Apple Distribution International Limited IE-AR-000012406
Sources (4)
- EUDAMED 1fb64fb6-b1d8-4775-a740-8cb1d9a815cc 61 fields · synced Jul 21, 2026
- FDA UDI 18c1f2d6-1274-4029-8e19-346fffc407cd 33 fields · synced May 30, 2026
- FDA UDI 2b1b94e2-6440-4ae5-b291-8f0d1a70f6d2 33 fields · synced May 30, 2026
- EUDAMED fae232f5-2bf7-47f8-914d-3fe74682b622 61 fields · synced Jul 21, 2026