Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS

Medisono

FDA UDI

Medisono, LLC·B369MUS05227·

MCI Medical Care Instruments GmbH

Importer

🇩🇪 Germany

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR

Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

FDA classification

FDA Class 1 ·Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

0068/QPZ-DM/172-2020

Certificate

MDD Annex V·JMI SYRINGES & MEDICAL DEVICES LTD.·MTIC InterCert S.r.l.·34 Basic UDI-DIs

HD 60147227 0001

Certificate

MDD Annex II Section 4·Shenzhen JCR Medical Technology Limited Company·TÜV Rheinland LGA Products GmbH·5 Basic UDI-DIs

KCI Manufacturing Unlimited Company

Authorized representative

🇮🇪 Ireland·3 Manufacturers

DCI DENTAL MALZEMELERİ VE TİCARET ANONİM ŞİRKETİ

Importer

🇹🇷 Türkiye

Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

FDA classification

FDA Class 2 ·Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

Azo Dye, Calcium

FDA classification

FDA Class 2 ·Azo Dye, Calcium

Zimmerman (Spectrophotometric), 17-Ketosteroids

FDA classification

FDA Class 1 ·Zimmerman (Spectrophotometric), 17-Ketosteroids

Analyzer, Gas, Nitrogen, Gaseous-Phase

FDA classification

FDA Class 2 ·Analyzer, Gas, Nitrogen, Gaseous-Phase

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR

25-OH-Vitamin D Total (CLIA)、25-OH-Vitamin D Total Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

MED-RAS GmbH Regulatory Affairs Service

Authorized representative

🇩🇪 Germany·18 Manufacturers·235 Devices

Piccolo Basic Metabolic Panel

FDA UDI

ABAXIS, INC.·EABA40000241·The Piccolo® Basic Metabolic Panel, used with t...

Agfa NV

Importer

🇧🇪 Belgium·8 Manufacturers