Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038896637

FEI Number

3038896637

Entity Name

IMENTUM MEDICAL LLC

City/State/Country

Irvine, CA, US

Establishment Address

186 Helix, Irvine, CA 92618, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Imentum Medical LLC (Owner Number: 10091731)

Owner / Operator Contact Address

186 Helix, Irvine, CA 92618, 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
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2025-06-04

Official Correspondent

Hantien Huang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Imentum Medical LLC

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 3038896637. Last updated year: 2026. Please use registration number 3038896637 when referencing this establishment in official correspondence.