Miltenyi Biotec B.V. & Co. KG
DE-MF-000005273 · Germany · Bergisch Gladbach
Miltenyi Biotec B.V. & Co. KG is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 19 |
|---|---|
| Class IIa | 17 |
Most frequent device types declared: Hardware configuration 2.
Among these devices, 29 are declared sterile, 5 active, 2 with a measuring function.
Devices declared under this manufacturer
- CliniMACS Prodigy
- CliniMACS Prodigy TS 310
- CliniMACS Prodigy TS 320
- CliniMACS Prodigy TS 510
- CliniMACS Tubing Set
- CryoMACS Freezing Bag 1000
- CryoMACS Freezing Bag 50
- CryoMACS Freezing Bag 500
- LIFE 21
- MACS ART Annexin V Reagent
- MACS TubeSealer
- TheraSorb - TS IA 100
Showing 12 of 36 declared devices.
Catalogue references include 161-01 / 200-073-104, 200-070-501, 200-070-502, 200-073-603, 200-074-402, 200-075-301.
European nomenclature codes declared: A0399, B0380, V9099, B0103, Z12170402, F01080102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Miltenyi Biotec B. V. & Co. KG (DE) · FDA 3005290010 |
| Devices in EUDAMED | 36 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 36 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 16.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MILTENYI BIOTEC B.V. & CO. KG |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 4 devices | 3 |
| First licensed | 2004-05-21 |
Licence types: System (3), Device Family (1).
Licensed under: CLINIMACS SYSTEM, CRYOMACS FREEZING BAG(S), CLINIMACS PRODIGY, CLINIMACS PRODIGY T CELL TRANSDUCTION (TCT) SY.
North American profile: Both markets. Miltenyi Biotec B.V. & Co. KG is registered in both the United States and Canada.