Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043048216

FEI Number

3043048216

Entity Name

Iris + Arlo Inc.

City/State/Country

Montreal Quebec, CA

Establishment Address

160 Saint Viateur Street East, Suite 202, Montreal Quebec H2T1A8, CA

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Iris + Arlo Inc. (Owner Number: 10094264)

Owner / Operator Contact Address

8 The Green, STE B, Dover, DE 19901, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Iris + Arlo Menstrual Pads and Pantyliners Iris + Arlo Organic Cotton Cardboard Applicator Tampons, Regular, Super and Super Plus Iris + Arlo Organic Cotton Non-Applicator Tampons Iris + Arlo Menstrual Cup

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2025-12-21
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2025-12-21
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2025-12-21
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2025-12-21

Official Correspondent

Damien Rambeaud

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

Iris + Arlo 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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02

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3017366514	FIBRIL TEX PVT LTD.	Amritsar Punjab, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043048216. Last updated year: 2026. Please use registration number 3043048216 when referencing this establishment in official correspondence.