Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005630901

FEI Number

3005630901

Entity Name

FridaBaby LLC

City/State/Country

Miami, FL, US

Establishment Address

82 NE 26th St, Suite 101, Miami, FL 33137, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Fridababy, LLC (Owner Number: 10052488)

Owner / Operator Contact Address

82 NE 26th Street, Miami, FL 33137, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Frida Fertility Ovulation Prediction Test Fridababy Training Toothbrush for Toddlers Fridababy Triple-Angle Toothhugger Fridababy Finger Toothbrush Fridababy Training Toothbrush for Babies Fridababy Grow-With-Me Training Toothbrush Set Baby Grooming Kit Smile Frida Kit FridaMom Anti-Nausea Bands One-Step Vaginal pH Tests Ultra-Quiet Portable Nebulizer Nebulizer Sterile Saline Prepare-to-Push Perineal Massage Wand 3-in-1 Nose, Nail + Ear Picker Nosefrida Saline Rinse Conception Friendly Lubricant Frida Mom Postpartum Abdominal Suport Binder C-Section Recovery Kit Fridababy DermaFrida THE FLAKEFIXER DermaFrida the SkinSoother Bath Accessories Kit, US, Postpartum Catch-All Pads MediFrida the Accu-Dose Pacifier Fridababy NoseFrida the Snotsucker Big Bundle of Joy Sick Day Prep Kit Bitty Bundle of Joy Fridababy NoseFrida The Snotsucker Saline Kit Baby Basics Kit Fridababy Electric NoseFrida Ultimate Baby Kit NoseFrida Hygiene Filters Frida Fertility Pee Collection Cup Frida Fertility Sperm Collection Cup frida mom Cooling Hydrogel Nipple Pads Ovulation and Pregnancy Test + Track Set Frida Fertility Early Detection Pregnancy Test Frida Mom C-Section Silicone Scar Patches Dual Support Belly Band Frida Fertility Conception Aid Cup Fridababy Windi the Gasspasser Fart Freeing Essentials Frida mom Upside Down Peri Bottle Medifrida

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2025-01-02
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2023-05-05
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2016-11-18
MVV	Device, Acupressure	Unknown	Class U	N/A	2022-06-30
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2026-04-30
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2024-05-10
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2022-12-26
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2025-07-10
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2020-03-09
PEB	Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible	Obstetrics/Gynecology	Class 2	884.5300	2024-04-04
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2021-12-27
GED	Brush, Dermabrasion, Manual	General, Plastic Surgery	Class 1	878.4800	2021-09-08
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2022-09-27
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-04-30
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2017-07-20
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-01-04
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2023-06-20
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-04-06
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2023-04-06
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2021-12-27
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2026-01-16
HDR	Cap, Cervical	Obstetrics/Gynecology	Class 2	884.5250	2023-11-27
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2020-02-05
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2021-11-30
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2022-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fridababy, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005833605	Nasalprodukter Sverige AB	Malmo Skane, SE
3030726486	FRIDABABY, LLC	Jacksonville, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400
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

Similar Registrations

Registration Number	Establishment Name	Location
3003965134	RECE INTERNATIONAL CORP.	Miami Lakes, FL, US
8010730	ALBERT HOHLKOERPER GMBH & CO. KG	HEMER North Rhine-Westphalia, DE
3031566471	TPH TECHNOLOGY MALAYSIA SDN. BHD.	Rawang Selangor, MY
3008957271	Mayborn Baby and Child / Jackel China Limited	Dong Guan Guangdong, CN
9710641	SEI Medical S.A. de C.V.	Juarez Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005630901. Last updated year: 2026. Please use registration number 3005630901 when referencing this establishment in official correspondence.