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Data / Medical devices / Sweden / Naturalcycles Nordic AB

Naturalcycles Nordic AB: FDA-registered device maker in Stockholm, Sweden, 6 510(k) clearances

Naturalcycles Nordic AB is registered with the FDA (registration 3014848805) in Stockholm, Sweden. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 21, 2025. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Naturalcycles Nordic AB
FDA registration number
3014848805
Address
St Eriksgatan 63b, Stockholm, Sweden, 11234
Owner or operator
Natural Cycles Nordic AB (10058341)
Roles
Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed
August 28, 2018
Registered through
2027
Brand names listed
Clearblue & Natural Cycles° Birth Control Kit Starter Pack, Clearblue & Natural Cycles° Birth Control Ovulation Test Refill Pack, Cycle Tracking, Natural Cycles, Natural Cycles Ovulation Test, Natural Cycles Pregnancy Test

Devices it lists

DeviceProduct codeClassRoleSource
Device, Fertility Diagnostic, Contraceptive, Software ApplicationPYT2Complaint file establishment, Manufactureraccessdata.fda.gov
Device, Fertility Diagnostic, ProceptiveLHDUComplaint file establishment, Manufactureraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Exporter to the US, Foreign private label distributoraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Exporter to the US, Foreign private label distributoraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Repackager or relabeleraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Exporter to the US, Foreign private label distributoraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 21, 2025K250561Natural CyclesPYTSubstantially EquivalentNatural Cycles Nordic ABaccessdata.fda.gov
July 11, 2024K241006Natural CyclesPYTSubstantially EquivalentNatural Cycles Nordic ABaccessdata.fda.gov
August 24, 2023K231274Natural CyclesPYTSubstantially EquivalentNatural Cycles Nordic ABaccessdata.fda.gov
June 24, 2021K202897Natural CyclesPYTSubstantially EquivalentNatural Cycles Nordic ABaccessdata.fda.gov
August 10, 2018DEN170052Natural CyclesPYTUnknownNatural Cycles Nordic ABaccessdata.fda.gov
April 8, 2005K043443ONE STEP HCG URINE PREGNANCY TESTLCXSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated March 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.