Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003697955

FEI Number

3003697955

Entity Name

MAI/GENESIS

City/State/Country

ELMWOOD, WI, US

Establishment Address

605 Pro-Ject Drive, ELMWOOD, WI 54740, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GENESIS INDUSTRIES, INC. (Owner Number: 2183741)

Owner / Operator Contact Address

303 SOUTH MCKAY AVE.,, P.O. BOX 39, SPRING VALLEY, WI 54767, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QUAD-TIP VAGINAL APPLICATOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2002-12-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GENESIS INDUSTRIES, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2183741	GENESIS INDUSTRIES, INC.	ELMWOOD, WI, US

Similar Registrations

Registration Number	Establishment Name	Location
3014462004	INGE SPA	Garbagnate Milanese Milano, IT
3017458128	Seed Health Inc	New York, NY, US
3019039128	B&A PRECISION SILICONE RUBBER (DONGGUAN) CO., LTD	Dongguan Guangdong, CN
3024676893	PANGAEA TECHNOLOGIES LLC	The Woodlands, TX, US
3017425145	Organon LLC	Jersey City, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003697955. Last updated year: 2026. Please use registration number 3003697955 when referencing this establishment in official correspondence.