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.
| 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 |
|
| US Agent |
|
| 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 |
Device Company | Device | Date |
|---|---|---|
| Ardo medical AG | Alyssa Hands-Free to-go 63.00.513 | 2025-09-23 |
| Ardo medical AG | Hospital Kit DeTach 24 mm 63.00.477 | 2025-09-04 |
| Ardo medical AG | Hospital Kit DeTach 21 mm 63.00.476 | 2025-09-04 |
| Ardo medical AG | Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115V 30.00.24 | 2025-07-24 |
| Ardo medical AG | Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115V 31.00.22 | 2025-07-24 |
| Ardo medical AG | Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit Fussschalter 30.00.22 | 2025-07-24 |
| Ardo medical AG | Hands-Free Double Pumpset 63.00.454 | 2024-01-30 |
| Ardo medical AG | Alyssa Hands-Free 63.00.453 | 2024-01-30 |
| Ardo medical AG | Double Clinic Pumpset 63.00.555 | 2023-09-14 |
| Ardo medical AG | Alyssa to-go 63.00.511 | 2023-06-01 |
| Ardo medical AG | Bellis 63.00.524 | 2023-06-01 |
| Ardo medical AG | Tulips Size S 63.00.23 | 2023-05-31 |
| Ardo medical AG | Tulips Size S 63.00.323 | 2023-05-31 |
| Ardo medical AG | Alyssa Double Plus 63.00.510 | 2022-08-25 |
| Ardo medical AG | Alyssa 63.00.509 | 2022-08-17 |
| Ardo medical AG | Amaryll 63.00.190 | 2022-08-12 |
ARDO Medical AG | ARDO Alyssa | 2022-04-15 |
| Ardo medical AG | Milk Bottles 150ml/5oz 63.00.349 | 2019-03-11 |
| Ardo medical AG | Single Pumpset 63.00.219 | 2019-03-11 |
| Ardo medical AG | Double Pumping Collection Kit 63.00.337 | 2018-10-25 |
| Ardo medical AG | Calypso Pro Complete 63.00.336 | 2018-10-25 |
| Ardo medical AG | Amaryll Start 63.00.191 | 2018-10-25 |
| Ardo medical AG | Tulips Size L 63.00.16 | 2018-10-25 |
| Ardo medical AG | Tulip Size M 63.00.15 | 2018-10-25 |
| Ardo medical AG | Tulips Size L 63.00.201 | 2018-10-25 |
| Ardo medical AG | Tulips Size M 63.00.204 | 2018-10-25 |
| Ardo medical AG | Amaryll Essentials 63.00.239 | 2018-10-25 |
| Ardo medical AG | Calypso To Go Pure 63.00.330 | 2018-07-06 |
| Ardo medical AG | Calypso Essentials TX 63.00.320 | 2018-07-06 |
| Ardo medical AG | OneMumPumpset D31 63.00.125 | 2018-07-06 |
| Ardo medical AG | OneMumPumpset D26 63.00.114 | 2018-07-06 |
| Ardo medical AG | Carum 61.00.74 | 2018-07-06 |
| Ardo medical AG | Carum Battery 63.00.77 | 2018-07-06 |
| Ardo medical AG | Calypso Essentials Plus 63.00.287 | 2018-07-06 |
| Ardo medical AG | Double Pumpset 63.00.222 | 2018-07-06 |
| Ardo medical AG | Calypso Pro Pump Unit 63.00.286 | 2018-07-06 |
| Ardo medical AG | Double Clinic Pumpset 63.00.283 | 2018-07-06 |
| Ardo medical AG | Calypso Pump Unit 63.00.282 | 2018-07-06 |
| Ardo medical AG | Calypso Pro 63.00.281 | 2018-07-06 |
| Ardo medical AG | Clinic Pumpset 26 mm 63.00.42 | 2018-07-06 |
| Ardo medical AG | Carum 63.00.73 | 2018-07-06 |
| Ardo medical AG | Easy Freeze 63.00.207 | 2018-07-06 |
| Ardo medical AG | Calypso Essentials 63.00.240 | 2018-07-06 |
| Ardo medical AG | Calypso-To-Go 63.00.243 | 2018-07-06 |
| Ardo medical AG | Calypso Double Plus 63.00.242 | 2018-07-06 |
Rene van de Zande [Ardo medical AG] | One Mum Pumpset D31 | 2017-12-11 |
Rene van de Zande [Ardo medical AG] | One Mum Pumpset D26 | 2017-12-11 |
Rene van de Zande [Ardo medical AG] | Breast Shell Insert D28 | 2017-12-11 |
Rene van de Zande [Ardo medical AG] | Breast Shell Insert D22 | 2017-12-11 |
Ardo Medical AG | One Mum Pumpset | 2017-11-29 |
Rene van de Zande [Ardo medical AG] | Calypso Pro | 2015-06-18 |
Rene van de Zande [Ardo medical AG] | Calypso Pro Pump Unit | 2015-06-18 |
Rene van de Zande [Ardo medical AG] | Calypso Pro Complete | 2015-06-18 |
ARDO MEDICAL AG | ARDO Calypso Pro Powered Breast Pump | 2015-06-17 |
Rene van de Zande [Ardo medical AG] | Single Pumpset | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Milk Bottles 150ml/5oz. | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Easy Freeze | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Double Pumpset | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Double Pumping Collection Kit | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Double Clinic Pumpset | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Clinic Pumpset D26 | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Carum | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Carum Battery | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Calypso-To-Go | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Calypso-To-Go Pure | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Calypso Pump Unit | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Calypso Essentials | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Calypso Essentials TX | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Calypso Essentials Plus | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Calypso Double Plus | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Tulips M | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Tulips M (100 pairs) | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Tulips L | 2014-12-23 |
Rene van de Zande [Ardo medical AG] | Tulips L (100 pairs) | 2014-12-23 |
ARDO MEDICAL AG | ARDO CARUM AND CALYPSO POWERED BREAST PUMPS | 2014-10-17 |
Rene van de Zande [Ardo medical AG] | ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX | 2012-05-02 |
Rene van de Zande [Ardo medical AG] | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX | 2012-05-02 |
Rene van de Zande [Ardo medical AG] | Amaryll Start | 2012-05-02 |
Rene van de Zande [Ardo medical AG] | Amaryll Essentials | 2012-05-02 |
ARDO MEDICAL AG | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX | 2001-06-08 |
| NCAGE Code | SHKF6 | ARDO MEDICAL AG |
| CAGE Code | SHKF6 | ARDO MEDICAL AG |
| 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 |