Liofilchem S.r.l.
Active in EUDAMEDItalyfrom SRN EUDAMED FDA SRN IT-MF-000026495 FEI 3012389632
- Devices
- 234
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
What Liofilchem S.r.l. makes
Liofilchem S.r.l. manufactures antimicrobial susceptibility test strips, including MIC (minimum inhibitory concentration) test strips for antibiotics such as dalbavancin, tedizolid, and plazomicin, as well as a ComASP test strip for cefiderocol. These products are designed for in vitro diagnostic use to determine bacterial resistance profiles and guide antimicrobial therapy. The strips cover a range of concentrations to measure susceptibility to specific antibiotics, aiding clinical decision-making in infectious disease management.
The company’s products are classified under EU Medical Device Regulations as Class A and Class II devices, reflecting varying levels of risk. These devices are registered in the EU’s euDaMed database and have undergone 510(k) clearance in the FDA’s registry. Liofilchem S.r.l. is based in Italy.
Catalogue
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Company details
- EUDAMED SRN
- IT-MF-000026495
- FDA FEI number
- 3012389632
- EU VAT number
- 00530130673
- EUDAMED status
- Active
- EUDAMED registered name
- Liofilchem S.r.l.
- Registered address
- snc, Via Scozia, 64026, Roseto Degli Abruzzi, Italy
- Website
- www.liofilchem.com
- [email protected]
- Phone
- +39 085 8930745
- PRRC contact
- Silvio Brocco