Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183930

FEI Number

1000116127

Entity Name

UMC INC.

City/State/Country

MONTICELLO, MN, US

Establishment Address

500 CHELSEA ROAD, MONTICELLO, MN 55362, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

UMC INC. (Owner Number: 9001095)

Owner / Operator Contact Address

500 CHELSEA ROAD, --, Monticello, MN 55362, 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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-02-04
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-02-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UMC INC.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183930. Last updated year: 2026. Please use registration number 2183930 when referencing this establishment in official correspondence.