Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027345797

FEI Number

3027345797

Entity Name

MODANE LABORATORIES, INC.

City/State/Country

Monona, WI, US

Establishment Address

2207 Industrial Dr., Monona, WI 53713, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Modane Laboratories, Inc. (Owner Number: 10088051)

Owner / Operator Contact Address

2207 Industrial Dr., Monona, WI 53713, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2023-05-18

Official Correspondent

Steve Kumbier

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Modane Laboratories, Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027345797. Last updated year: 2026. Please use registration number 3027345797 when referencing this establishment in official correspondence.