Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003509351

FEI Number

3003509351

Entity Name

ARDO MEDICAL AG

City/State/Country

UNTERAEGERI Zug, CH

Establishment Address

Gewerbestrasse 19, UNTERAEGERI Zug 6314, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ardo medical AG (Owner Number: 10040647)

Owner / Operator Contact Address

Gewerbestrasse 19, Unteraegeri, CH-ZG 6314, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ardo Bellis Amaryll Essentials Amaryll Start Ardo Alyssa Ardo Alyssa Double Ardo Alyssa to-go Ardo Alyssa Double Plus Ardo Alyssa Hands-Free Ardo Alyssa pump unit Ardo Alyssa Hands-Free to-go Ardo Alyssa Conversion Kit Calypso Pro Calypso Pro Complete Calypso Pro Pump Unit Double Pumping Collection Kit Calypso Pump Unit Easy Freeze Carum Clinic Pumpset D26 Calypso-To-Go Calypso Essentials TX Double Clinic Pumpset Calypso-To-Go Pure Calypso Double Plus Calypso Essentials Single Pumpset Double Pumpset Calypso Essentials Plus Carum Battery Milk Bottles 150ml/5oz. Breast Shell Insert Hands-Free Double Pumpset Hands-Free Collection Cups ARDO SUCTION PUMP MASTER, MODEL 300.XX ARDO SUCTION PUMP SENATOR, MODEL 310.XX 300.24 / UP034C Master 115V 300.22 / UP033C Master 115V with foot switch 310.22 / UP030C Senator 115V Tulips M (100 pairs) Tulips M Tulips L Tulips L (100 pairs) Tulips S Tulips S (100 pairs)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-04-06
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2012-05-02
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-05-11
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2015-06-18
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2014-12-23
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2012-05-02
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2014-12-23

Official Correspondent

Maya Waldvogel

US Agent Details

Nikolaos Papadopoulos Business: Ardo medical, Inc. Email: nic@ardomedical.com Phone: (844) 4112736

Related Public Records

Same Entity

Ardo medical AG

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
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003509351. Last updated year: 2026. Please use registration number 3003509351 when referencing this establishment in official correspondence.