FDA Registration
Active
🇺🇸 United States
FridaBaby LLC
Reg #: 3005630901
·
FEI: 3005630901
·
Expires 2026
Products
34
Proprietary Names
65
Establishment Types
2
Classifications
34
Registration Details
- Registration Name
- FridaBaby LLC
- Registration Number
- 3005630901
- FEI Number
- 3005630901
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 82 NE 26th St, Suite 101
- City
- Miami
- State
- FL
- ZIP
- 33137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220289
Owner / Operator
- Firm Name
- Fridababy, LLC
- Operator Number
- 10052488
- Address
- 82 NE 26th Street
- City
- Miami
- State
- FL
- Postal Code
- 33137
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2025-01-02 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2023-05-05 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2016-11-18 |
| Device, Acupressure | MVV | Class U | Unknown | No | 2022-06-30 |
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2026-04-30 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2024-05-10 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2022-12-26 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2025-07-10 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2020-03-09 |
| Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | PEB | Class 2 | Obstetrics/Gynecology | No | 2024-04-04 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2021-12-27 |
| Brush, Dermabrasion, Manual | GED | Class 1 | General, Plastic Surgery | No | 2021-09-08 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2022-09-27 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2019-04-30 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2017-07-20 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2023-01-04 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2023-06-20 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2023-04-06 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2023-04-06 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2021-12-27 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2026-01-16 |
| Cap, Cervical | HDR | Class 2 | Obstetrics/Gynecology | No | 2023-11-27 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 2020-02-05 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2021-11-30 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2022-01-28 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2020-12-21 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2020-12-04 |
| Ring, Teething, Fluid-Filled | KKO | Class 2 | Dental | No | 2023-11-08 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-10 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2023-01-04 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-01-06 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2021-04-08 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2021-12-27 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2024-06-24 |
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
Fridamom 2-in-1 Lactation Massager
Breast Care Self Care Kit
Fridamom Instant Heat Breast Warmers
Frida Mom C-Section Recovery Band
Hot + Cold Breast Relief Packs
Breastfeeding Survival Kit, US
Fridababy Gas + Colic Heating Pad
Frida Mom Nursing Pillow Back + Belly Warmers
Not-Too-Cold-To-Hold Teether
Quick-Read Digital Rectal Thermometer
3-in-1 Ear, Forehead, + Touchless Thermometer
3-in-1 True Temp Thermometer
Frida Fertility At-Home Insemination Set
12300100, 12101100
Fridamom Instant Instant Ice Maxi Pad
Fridababy FeverFrida THE COOL PADS
Postpartum Recovery Essentials Kit
Labor and Delivery + Postpartum Recovery Kit
Motherload[ed] Hospital Bag Kit
Frida Mom Pain + Strain Relief Tape
NoseFrida Saline Mist Inhaler
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198