Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014848805

FEI Number

3014848805

Entity Name

NATURALCYCLES NORDIC AB

City/State/Country

Stockholm, SE

Establishment Address

St Eriksgatan 63b, Stockholm 11234, SE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Natural Cycles Nordic AB (Owner Number: 10058341)

Owner / Operator Contact Address

St Eriksgatan 63b, Stockholm, SE-AB 11234, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cycle Tracking Natural Cycles Pregnancy Test Natural Cycles Clearblue & Natural Cycles° Birth Control Kit Starter Pack Clearblue & Natural Cycles° Birth Control Ovulation Test Refill Pack Natural Cycles Natural Cycles Natural Cycles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHD	Device, Fertility Diagnostic, Proceptive	Unknown	Class U	N/A	2022-11-30
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-03-11
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2022-03-11
PYT	Device, Fertility Diagnostic, Contraceptive, Software Application	Obstetrics/Gynecology	Class 2	884.5370	2023-09-15
PYT	Device, Fertility Diagnostic, Contraceptive, Software Application	Obstetrics/Gynecology	Class 2	884.5370	2025-02-05
PYT	Device, Fertility Diagnostic, Contraceptive, Software Application	Obstetrics/Gynecology	Class 2	884.5370	2025-04-28
PYT	Device, Fertility Diagnostic, Contraceptive, Software Application	Obstetrics/Gynecology	Class 2	884.5370	2018-08-28
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2021-10-08

Official Correspondent

Raoul Scherwitzl

US Agent Details

Raoul Scherwitzl Email: raoul.scherwitzl@naturalcycles.com Phone: (413) 3308578

Related Public Records

Same Entity

Natural Cycles Nordic AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07
K043443	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE PREGNANCY TEST	2005-04-08
K173229	Guangzhou Wondfo Biotech Co., Ltd.	Preview Digital Pregnancy Test	2018-03-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014848805. Last updated year: 2026. Please use registration number 3014848805 when referencing this establishment in official correspondence.