IRIS USA INC

FDA Device Registration & Listing · Pleasant Prairie, WI, US · Registration 3002813051

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
3002813051
FEI Number
3002813051
Entity Name
IRIS USA INC
City/State/Country
Pleasant Prairie, WI, US
Establishment Address
11111 80th Ave, Pleasant Prairie, WI 53158, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
IRIS USA INC (Owner Number: 10093997)
Owner / Operator Contact Address
11111 80 th ave, Pleasant Prairie, WI 53158, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230380
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
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-09-05

Official Correspondent

Jimmie Henderson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IRIS USA INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002813051. Last updated year: 2026. Please use registration number 3002813051 when referencing this establishment in official correspondence.
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