Identity
- Trade Name
- Natural Cycles FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app. FDA UDI
- Model / Reference
- 13 FDA UDI
- Description
- Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350014630131 FDA UDI
- 510(k) Number
- DEN170052 FDA UDI
- FDA Product Code
- PYT FDA UDI
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Self-care monitoring/reporting software
Natural Cycles by Natural Cycles Nordic AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN170052 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Natural Cycles Nordic AB
Sources (1)
- FDA UDI f179fa4d-f6f8-4619-88cc-6b0797371432 34 fields · synced May 30, 2026