Natural Cycles Ovulation Tests

GUDID 17350014630145

Naturalcycles Nordic AB

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Primary Device ID17350014630145
NIH Device Record Keyb37da244-e324-4c73-aa0d-d8fa2660047e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNatural Cycles Ovulation Tests
Version Model NumberW00210329
Company DUNS352550104
Company NameNaturalcycles Nordic AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117350014630145 [Primary]

FDA Product Code

NGETest, Luteinizing Hormone (Lh), Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-22
Device Publish Date2023-05-14

Devices Manufactured by Naturalcycles Nordic AB

04719003114114 - Natural Cycles2024-09-26
17350014630145 - Natural Cycles Ovulation Tests2023-05-22
17350014630145 - Natural Cycles Ovulation Tests2023-05-22
17350014630152 - Natural Cycles Pregnancy Tests2023-05-22
07350014630100 - Cycle Tracking2023-04-27
07350014630155 - Natural Cycles2022-10-31 Test, Pregnancy, Hcg, Over The Counter
07350014630148 - Natural Cycles2022-06-10 Test, Luteinizing Hormone (Lh), Over The Counter
07350014630285 - Clearblue by NC2021-11-22
07350014630209 - Natural Cycles2020-02-17 Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy str

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