Identity
- Trade Name
- Natural Cycles FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy strip tests. FDA UDI
- Model / Reference
- 20 FDA UDI
- Description
- Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy strip tests. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350014630209 FDA UDI
- FDA Product Code
- LCX FDA UDIPYT FDA UDINGE FDA UDI
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 FDA UDI884.5370 FDA UDI862.1485 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
Yes
FDA UDI
Convenience Kit
Yes
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: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinicalSelf-care monitoring/reporting softwareLuteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Natural Cycles by Natural Cycles Nordic AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical.
- AMPLIM — AMPLIM, LLC · Class II
- Natalist Ovulation Test — Equinox Biotech Co., Ltd. · Class I
- AMPLIM — AMPLIM, LLC · Class II
- INSTANT-VIEW LH Ovulation Predicting Cassette Test — Alfa Scientific Designs, Inc. · Class I
- Mosie Baby Ovulation Test — GERMAINE LABORATORIES, INC. · Class I
- FERTICARE — Weihai Kangzhou Biotechnology Engineering Co., Ltd · Class I
- Modern Fertility Ovulation Test — MODERN HEALTH · Class I
- OvuSign® LH card — PRINCETON BIOMEDITECH CORP. · Class I
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 b9fa3f2a-556c-4737-a8ef-279118b5bf74 33 fields · synced Jun 8, 2026