INVO Fertility, Inc.

FDA Device Registration & Listing · Sarasota, FL, US · Registration 3008101047

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008101047
FEI Number
3008101047
Entity Name
INVO Fertility, Inc.
City/State/Country
Sarasota, FL, US
Establishment Address
5582 Broadcast Court, Sarasota, FL 34240, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
INVO Fertility, Inc. (Owner Number: 10035355)
Owner / Operator Contact Address
5582 Broadcast Court, Sarasota, FL 34240, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN150008
PMA Number
N/A

All Registered Proprietary Names

INVOcell

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OYO Culture, Intravaginal, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6165 2016-01-23

Official Correspondent

Chris Jensen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INVO Fertility, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
1225492 NextPhase Medical Devices LLC ROCHESTER, NH, US
3028606342 OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD Guangzhou Guangdong, CN
3038274470 BRAINMATTERZ, INC McKinney, TX, US
3012404174 LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL. Schio Vicenza, IT
3042364673 NEURALYTIX LLC Fruita, CO, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008101047. Last updated year: 2026. Please use registration number 3008101047 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.