OMARE, SL

Importer

🇪🇸 Spain·3 Manufacturers

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Enteral Specific Transition Connectors

FDA classification

FDA Class 2 ·Enteral Specific Transition Connectors

Enteral Syringes With Enteral Specific Connectors

FDA classification

FDA Class 2 ·Enteral Syringes With Enteral Specific Connectors

qct-0120-19

Certificate

MDD Annex II (excluding section 4)·G P S S.R.L. ·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

QCT-0120-19

Certificate

MDD Annex II (excluding section 4)·G P S S.R.L. ·ISTITUTO SUPERIORE DI SANITA'·3 Basic UDI-DIs

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

BSW Ipari, Kereskedelmi és Szolgáltató Kft.

System producer

🇭🇺 Hungary

Sentiero Advanced

FDA UDI

PATH medical GmbH·04260223145247·Sentiero Advanced ABR, OAE, Tympanometry and Au...

Sentiero Advanced

FDA UDI

PATH medical GmbH·04260223145230·Sentiero Advanced ABR, OAE, Tympanometry and Au...

Compagnia Italiana Oftalmologica scarl

Importer

🇮🇹 Italy·8 Manufacturers

France Chirurgie Instrumentation SAS

Importer

🇫🇷 France·13 Manufacturers

W2O Medizintechnik AG

Importer

🇩🇪 Germany·14 Manufacturers

E202-5077/0I

FDA registration

Metko Medikal ve Tibbi Cihazlar Dis Ticaret Sanayi A.S.·1 product·🇹🇷 Türkiye

Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

FDA classification

FDA Unclassified ·Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

FDA classification

FDA Unclassified ·Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Kuomed Oy

Importer

🇫🇮 Finland·21 Manufacturers

ADVIA Centaur

FDA registration

Siemens Healthcare Diagnostics Inc.·41 products·🇺🇸 United States