Ardo Medical Ag

FDA Filings

This page includes the latest FDA filings for Ardo Medical Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003509351
• FEI Number: 3003509351
• Name: Rene van de Zande
• Owner & Operator: Ardo medical AG
• Contact Address: Gewerbestrasse 19 ; UNTERAEGERI CH-ZG Zug 6314 CH
• Official Correspondent:
  • Thomas Schlieper; Dr.
  • 041-41-7547070-x
• US Agent:
  • Rene van de Zande
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07640108054494 Ardo medical AG	Hands-Free Double Pumpset 63.00.454	2024-01-30
GUDID 07640108054470 Ardo medical AG	Alyssa Hands-Free 63.00.453	2024-01-30
GUDID 00814079022210 Ardo medical AG	Double Clinic Pumpset 63.00.555	2023-09-14
GUDID 07640108053961 Ardo medical AG	Alyssa to-go 63.00.511	2023-06-01
GUDID 07640108051516 Ardo medical AG	Bellis 63.00.524	2023-06-01
GUDID 07640109059627 Ardo medical AG	Tulips Size S 63.00.23	2023-05-31
GUDID 00814079022111 Ardo medical AG	Tulips Size S 63.00.323	2023-05-31
GUDID 07640108053640 Ardo medical AG	Alyssa Double Plus 63.00.510	2022-08-25
GUDID 07640108053541 Ardo medical AG	Alyssa 63.00.509	2022-08-17
GUDID 00814079020100 Ardo medical AG	Amaryll 63.00.190	2022-08-12
PMN K212773 ARDO Medical AG	ARDO Alyssa	2022-04-15
GUDID 00814079022050 Ardo medical AG	Milk Bottles 150ml/5oz 63.00.349	2019-03-11
GUDID 00814079021442 Ardo medical AG	Single Pumpset 63.00.219	2019-03-11
GUDID 00814079022005 Ardo medical AG	Double Pumping Collection Kit 63.00.337	2018-10-25
GUDID 00814079021992 Ardo medical AG	Calypso Pro Complete 63.00.336	2018-10-25
GUDID 00814079021398 Ardo medical AG	Amaryll Start 63.00.191	2018-10-25
GUDID 00814079020728 Ardo medical AG	Tulips Size L 63.00.16	2018-10-25
GUDID 00814079020698 Ardo medical AG	Tulip Size M 63.00.15	2018-10-25
GUDID 00814079020193 Ardo medical AG	Tulips Size L 63.00.201	2018-10-25
GUDID 00814079020162 Ardo medical AG	Tulips Size M 63.00.204	2018-10-25
GUDID 00814079020131 Ardo medical AG	Amaryll Essentials 63.00.239	2018-10-25
GUDID 00814079021909 Ardo medical AG	Calypso To Go Pure 63.00.330	2018-07-06
GUDID 00814079021800 Ardo medical AG	Calypso Essentials TX 63.00.320	2018-07-06
GUDID 00814079021657 Ardo medical AG	OneMumPumpset D31 63.00.125	2018-07-06
GUDID 00814079021541 Ardo medical AG	OneMumPumpset D26 63.00.114	2018-07-06
GUDID 00814079021053 Ardo medical AG	Carum 61.00.74	2018-07-06
GUDID 00814079021022 Ardo medical AG	Carum Battery 63.00.77	2018-07-06
GUDID 00814079020964 Ardo medical AG	Calypso Essentials Plus 63.00.287	2018-07-06
GUDID 00814079020933 Ardo medical AG	Double Pumpset 63.00.222	2018-07-06
GUDID 00814079020919 Ardo medical AG	Calypso Pro Pump Unit 63.00.286	2018-07-06
GUDID 00814079020872 Ardo medical AG	Double Clinic Pumpset 63.00.283	2018-07-06
GUDID 00814079020858 Ardo medical AG	Calypso Pump Unit 63.00.282	2018-07-06
GUDID 00814079020810 Ardo medical AG	Calypso Pro 63.00.281	2018-07-06
GUDID 00814079020667 Ardo medical AG	Clinic Pumpset 26 mm 63.00.42	2018-07-06
GUDID 00814079020605 Ardo medical AG	Carum 63.00.73	2018-07-06
GUDID 00814079020216 Ardo medical AG	Easy Freeze 63.00.207	2018-07-06
GUDID 00814079020063 Ardo medical AG	Calypso Essentials 63.00.240	2018-07-06
GUDID 00814079020049 Ardo medical AG	Calypso-To-Go 63.00.243	2018-07-06
GUDID 00814079020001 Ardo medical AG	Calypso Double Plus 63.00.242	2018-07-06
PMN K172067 | HGX Rene van de Zande [Ardo medical AG]	One Mum Pumpset D31	2017-12-11
PMN K172067 | HGX Rene van de Zande [Ardo medical AG]	One Mum Pumpset D26	2017-12-11
PMN K172067 | HGX Rene van de Zande [Ardo medical AG]	Breast Shell Insert D28	2017-12-11
PMN K172067 | HGX Rene van de Zande [Ardo medical AG]	Breast Shell Insert D22	2017-12-11
PMN K172067 Ardo Medical AG	One Mum Pumpset	2017-11-29
PMN K150721 | HGX Rene van de Zande [Ardo medical AG]	Calypso Pro	2015-06-18
PMN K150721 | HGX Rene van de Zande [Ardo medical AG]	Calypso Pro Pump Unit	2015-06-18
PMN K150721 | HGX Rene van de Zande [Ardo medical AG]	Calypso Pro Complete	2015-06-18
PMN K150721 ARDO MEDICAL AG	ARDO Calypso Pro Powered Breast Pump	2015-06-17
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Single Pumpset	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Milk Bottles 150ml/5oz.	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Easy Freeze	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Double Pumpset	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Double Pumping Collection Kit	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Double Clinic Pumpset	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Clinic Pumpset D26	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Carum	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Carum Battery	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Calypso-To-Go	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Calypso-To-Go Pure	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Calypso Pump Unit	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Calypso Essentials	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Calypso Essentials TX	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Calypso Essentials Plus	2014-12-23
PMN K141742 | HGX Rene van de Zande [Ardo medical AG]	Calypso Double Plus	2014-12-23
HFS Rene van de Zande [Ardo medical AG]	Tulips M	2014-12-23
HFS Rene van de Zande [Ardo medical AG]	Tulips M (100 pairs)	2014-12-23
HFS Rene van de Zande [Ardo medical AG]	Tulips L	2014-12-23
HFS Rene van de Zande [Ardo medical AG]	Tulips L (100 pairs)	2014-12-23
PMN K141742 ARDO MEDICAL AG	ARDO CARUM AND CALYPSO POWERED BREAST PUMPS	2014-10-17
PMN K011601 | BTA Rene van de Zande [Ardo medical AG]	ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX	2012-05-02
PMN K011601 | BTA Rene van de Zande [Ardo medical AG]	ARDO SUCTION PUMP MASTER, MODEL 30.00.XX	2012-05-02
HGY Rene van de Zande [Ardo medical AG]	Amaryll Start	2012-05-02
HGY Rene van de Zande [Ardo medical AG]	Amaryll Essentials	2012-05-02
PMN K011601 ARDO MEDICAL AG	ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX	2001-06-08

Related Finance Registrations

NCAGE Code	SHKF6	ARDO MEDICAL AG
CAGE Code	SHKF6	ARDO MEDICAL AG

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092998598	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	S.L.A.C. ON 7 PALLETS MEDICAL EQUIPMENT, CA R ADAPTERS 2ND NOTIFY MID-AMERICA OVERSEAS,	1276 PCS
202009285056	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	S.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND	1448 PCS
202009255793	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	S.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND	1448 PCS
2020090447373	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	S.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND	1448 PCS
2020090165162	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	S.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND	1448 PCS
2020082655446	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	S.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND	1448 PCS
2020072771344	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	S.L.A.C. ON 9 PALLETS MEDICAL EQUIPMENT, CA R ADAPTERS HS-CODE 9018.9000, 3926.9000, 420	1576 PCS
2020071813394	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	S.L.A.C. MEDICAL EQUIPMENT, CAR ADAPTERS HS-C ODE 8544.4221, 9018.9000 2ND NOTIFY MID-AME	6 PCS