Maquet Cardiopulmonary GmbH
DE-MF-000020091 · Germany · Rastatt
Maquet Cardiopulmonary GmbH is registered in the European database on medical devices as a manufacturer, with 94 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 26 |
|---|---|
| Class IIb | 26 |
| Class IIa | 42 |
Most frequent device types declared: 10020-CE, 10027-CE, BE-MECC 50310, BE-PAL 1923, BE-PAL 2123.
Among these devices, 60 are declared sterile, 25 active, 6 with a measuring function.
Devices declared under this manufacturer
- Art. HLS cannula OD = 15 Fr (5.0 mm) 3/8\
- Art. HLS cannula OD = 17 Fr (5.7 mm) 3/8\
- Art. HLS cannula OD = 19 Fr (6.3 mm) 3/8\
- Art. HLS cannula OD = 21 Fr (7.0 mm) 3/8\
- Avalon Elite® Bi-Caval Dual Lumen Catheter
- Cardiohelp II Venous Probe
- Heater Unit HU 35
- Heater Unit HU 35, 110-115V
- National UK NRP pack \
- Percutaneous Insertion Kit (scalpel, puncture needle, guidewire 150 cm
- ROTAFLOW Centrifugal Pump
- Sprinter Cart
Showing 12 of 94 declared devices.
Catalogue references include 701047283, 701047287, 701047385, 701047813, 701072130, 701072131.
European nomenclature codes declared: C03010499, Z12050280, C030199, C0301040202, C03010301, C0699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MAQUET CARDIOPULMONARY GmbH (DE) · FDA 8010762 |
| Devices in EUDAMED | 94 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 94 |
|---|---|
| Found in the U.S. device database | 16 |
| Share | 17.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MAQUET CARDIOPULMONARY GMBH |
What it holds in Canada
| Licences on record | 24 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 13 |
| Class 3 devices | 5 |
| Class 4 devices | 6 |
| First licensed | 2000-10-13 |
Licence types: Device Group Family (10), Device Family (6), System (5), Single Device (2).
Licensed under: ROTAFLOW CENTRIFUGAL PUMPS, QUADROX OXYGENATOR, FEMORAL CANNULAE SETS, PVC TUBING FOR CARDIOPULMONARY BYPASS, ECC ACCESSORY LINE-PVC, ROTAFLOW CARDIO PULMONARY BYPASS CENTRIFUGAL P.
North American profile: Both markets. Maquet Cardiopulmonary GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 067154 0016 | issued | 2028-07-25 |