SABEU GmbH & Co. KG
Country not established FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What SABEU GmbH & Co. KG makes
SABEU GmbH & Co. KG manufactures in vitro diagnostic (IVD) devices focused on fluid specimen concentration filters, specifically designed for processing and preparing cell samples. Their product line includes the cellQART®, which is used to concentrate and isolate cells from liquid biological specimens for downstream analysis or testing.
The company’s devices are classified as Class I under regulatory frameworks, indicating minimal risk and typically requiring only general controls for compliance. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory tracking in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Company details
- DUNS number
- 316894864
- [email protected]
- Phone
- +495551910100
FDA establishments
- Sabeu GmbH & Co. KG Northeim Lower Saxony · DE FEI 3015294637
Frequently asked questions
How many devices does SABEU GmbH & Co. KG have in the registry?
The registry currently lists 6 devices for SABEU GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.
Which registries list SABEU GmbH & Co. KG's devices?
Among its 6 most recently registered devices, SABEU GmbH & Co. KG has devices listed in FDA GUDID (6 devices).
What risk classes do SABEU GmbH & Co. KG's devices fall under?
Among its 6 most recently registered devices, the classes recorded for SABEU GmbH & Co. KG's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from SABEU GmbH & Co. KG in the registry?
The most recently registered devices listed for SABEU GmbH & Co. KG include cytoQ® Urine Filters, cytoQ® Gyn Filters, cytoQ® Non-Gyn Filters and cellQART® cytoQART URINE Filters.
Which FDA establishments are linked to SABEU GmbH & Co. KG?
1 FDA establishment is linked to SABEU GmbH & Co. KG in the registry; they are listed on the company page.