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 Number3003509351
FEI Number3003509351
NameRene van de Zande
Owner & OperatorArdo medical AG
Contact AddressGewerbestrasse 19
UNTERAEGERI CH-ZG Zug 6314 CH
Official Correspondent
  • Thomas Schlieper; Dr.
  • 041-41-7547070-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ARDO Medical AG
ARDO Alyssa2022-04-15
Ardo medical AG
Milk Bottles 150ml/5oz 63.00.3492019-03-11
Ardo medical AG
Single Pumpset 63.00.2192019-03-11
Ardo medical AG
Double Pumping Collection Kit 63.00.3372018-10-25
Ardo medical AG
Calypso Pro Complete 63.00.3362018-10-25
Ardo medical AG
Amaryll Start 63.00.1912018-10-25
Ardo medical AG
Tulips Size L 63.00.162018-10-25
Ardo medical AG
Tulip Size M 63.00.152018-10-25
Ardo medical AG
Tulips Size L 63.00.2012018-10-25
Ardo medical AG
Tulips Size M 63.00.2042018-10-25
Ardo medical AG
Amaryll Essentials 63.00.2392018-10-25
Ardo medical AG
Calypso To Go Pure 63.00.3302018-07-06
Ardo medical AG
Calypso Essentials TX 63.00.3202018-07-06
Ardo medical AG
OneMumPumpset D31 63.00.1252018-07-06
Ardo medical AG
OneMumPumpset D26 63.00.1142018-07-06
Ardo medical AG
Carum 61.00.742018-07-06
Ardo medical AG
Carum Battery 63.00.772018-07-06
Ardo medical AG
Calypso Essentials Plus 63.00.2872018-07-06
Ardo medical AG
Double Pumpset 63.00.2222018-07-06
Ardo medical AG
Calypso Pro Pump Unit 63.00.2862018-07-06
Ardo medical AG
Double Clinic Pumpset 63.00.2832018-07-06
Ardo medical AG
Calypso Pump Unit 63.00.2822018-07-06
Ardo medical AG
Calypso Pro 63.00.2812018-07-06
Ardo medical AG
Clinic Pumpset 26 mm 63.00.422018-07-06
Ardo medical AG
Carum 63.00.732018-07-06
Ardo medical AG
Easy Freeze 63.00.2072018-07-06
Ardo medical AG
Calypso Essentials 63.00.2402018-07-06
Ardo medical AG
Calypso-To-Go 63.00.2432018-07-06
Ardo medical AG
Calypso Double Plus 63.00.2422018-07-06
Rene van de Zande [Ardo medical AG]
One Mum Pumpset D312017-12-11
Rene van de Zande [Ardo medical AG]
One Mum Pumpset D262017-12-11
Rene van de Zande [Ardo medical AG]
Breast Shell Insert D282017-12-11
Rene van de Zande [Ardo medical AG]
Breast Shell Insert D222017-12-11
Ardo Medical AG
One Mum Pumpset2017-11-29
Rene van de Zande [Ardo medical AG]
Calypso Pro2015-06-18
Rene van de Zande [Ardo medical AG]
Calypso Pro Pump Unit2015-06-18
Rene van de Zande [Ardo medical AG]
Calypso Pro Complete2015-06-18
ARDO MEDICAL AG
ARDO Calypso Pro Powered Breast Pump2015-06-17
Rene van de Zande [Ardo medical AG]
Single Pumpset2014-12-23
Rene van de Zande [Ardo medical AG]
Milk Bottles 150ml/5oz.2014-12-23
Rene van de Zande [Ardo medical AG]
Easy Freeze2014-12-23
Rene van de Zande [Ardo medical AG]
Double Pumpset2014-12-23
Rene van de Zande [Ardo medical AG]
Double Pumping Collection Kit2014-12-23
Rene van de Zande [Ardo medical AG]
Double Clinic Pumpset2014-12-23
Rene van de Zande [Ardo medical AG]
Clinic Pumpset D262014-12-23
Rene van de Zande [Ardo medical AG]
Carum2014-12-23
Rene van de Zande [Ardo medical AG]
Carum Battery2014-12-23
Rene van de Zande [Ardo medical AG]
Calypso-To-Go2014-12-23
Rene van de Zande [Ardo medical AG]
Calypso-To-Go Pure2014-12-23
Rene van de Zande [Ardo medical AG]
Calypso Pump Unit2014-12-23
Rene van de Zande [Ardo medical AG]
Calypso Essentials2014-12-23
Rene van de Zande [Ardo medical AG]
Calypso Essentials TX2014-12-23
Rene van de Zande [Ardo medical AG]
Calypso Essentials Plus2014-12-23
Rene van de Zande [Ardo medical AG]
Calypso Double Plus2014-12-23
Rene van de Zande [Ardo medical AG]
Tulips M2014-12-23
Rene van de Zande [Ardo medical AG]
Tulips M (100 pairs)2014-12-23
Rene van de Zande [Ardo medical AG]
Tulips L2014-12-23
Rene van de Zande [Ardo medical AG]
Tulips L (100 pairs)2014-12-23
ARDO MEDICAL AG
ARDO CARUM AND CALYPSO POWERED BREAST PUMPS2014-10-17
Rene van de Zande [Ardo medical AG]
ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX2012-05-02
Rene van de Zande [Ardo medical AG]
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX2012-05-02
Rene van de Zande [Ardo medical AG]
Amaryll Start2012-05-02
Rene van de Zande [Ardo medical AG]
Amaryll Essentials2012-05-02
ARDO MEDICAL AG
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX2001-06-08

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092998598Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyS.L.A.C. ON 7 PALLETS MEDICAL EQUIPMENT, CA R ADAPTERS 2ND NOTIFY MID-AMERICA OVERSEAS,1276 PCS
202009285056Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyS.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND1448 PCS
202009255793Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyS.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND1448 PCS
2020090447373Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyS.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND1448 PCS
2020090165162Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyS.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND1448 PCS
2020082655446Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyS.L.A.C. ON 10 PALLETS MEDICAL EQUIPMENT, C AR ADAPTERS HS-CODE 9018.9000, 3926.9000 2ND1448 PCS
2020072771344Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyS.L.A.C. ON 9 PALLETS MEDICAL EQUIPMENT, CA R ADAPTERS HS-CODE 9018.9000, 3926.9000, 4201576 PCS
2020071813394Anvers,Belgium -> New York/Newark Area, Newark, New JerseyS.L.A.C. MEDICAL EQUIPMENT, CAR ADAPTERS HS-C ODE 8544.4221, 9018.9000 2ND NOTIFY MID-AME6 PCS

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