Stratec Se
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000007261 FEI 3003413192
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Stratec Se makes
Stratec SE manufactures laboratory instruments, including the KleeYa® Instrument—a device for immunoassay analysis—and the Gemini Compact Microplate Processor, designed for automated processing of microplates in research or clinical settings.
These products fall under EU Device Class A and are registered in the EUDAMED database. The company is based in Germany.
Catalogue
KleeYa® Instrument Ref 10108093
Regimes: CE IVDR Registry: EUDAMEDGUDIDGemini Compact Microplate Processor Ref 10041566
Regimes: CE IVDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- DE-MF-000007261
- FDA FEI number
- 3003413192
- DUNS number
- 340361455
- EU VAT number
- DE 812 415 108
- EUDAMED status
- Active
- EUDAMED registered name
- STRATEC SE
- EUDAMED abbreviated name
- STRATEC SE
- Registered address
- 37, Gewerbestraße, 75217, Birkenfeld, Germany
- Website
- www.stratec.com
- [email protected]
- Phone
- +49708279160
- PRRC contact
- Michael Rothhaar
Frequently asked questions
How many devices does STRATEC SE have in the registry?
The registry currently lists 2 devices for STRATEC SE. Devices recorded under merged duplicate company entries are counted once.
Which registries list STRATEC SE's devices?
Among its 2 most recently registered devices, STRATEC SE has devices listed in EUDAMED (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do STRATEC SE's devices fall under?
Among its 2 most recently registered devices, the classes recorded for STRATEC SE's devices are IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from STRATEC SE in the registry?
The most recently registered devices listed for STRATEC SE include KleeYa® Instrument and Gemini Compact Microplate Processor.