Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI

Anti-Jcv Antibody Detection Assay

FDA classification

FDA Class 2 ·Anti-Jcv Antibody Detection Assay

BCI COMP. SPO2 AD CB, LEMO TO 9 PIN, 10

FDA UDI

CURBELL MEDICAL PRODUCTS, INC.·00840828146340·BCI COMP. SPO2 AD CB, LEMO TO 9 PIN, 10

Homocysteine （HCY）Assay Kit (Enzymatic Cycling Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

Jig, Piston Cutting, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Jig, Piston Cutting, Ent, Non-Sterile

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

FDA Pre-Market Approval

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

Dental Components Sebastian Gałat

Importer

🇵🇱 Poland·1 Manufacturer

KCI Polymedics BV

Importer

🇧🇪 Belgium·1 Manufacturer

DENTAL COMPONENTS EUROPE

Authorized representative

🇫🇷 France·1 Manufacturer·2 Devices

Medicon Hellas Total Bilirubin

FDA registration

MEDICON HELLAS SA·6 products·🇬🇷 Greece

PINCHET RX SRL

Importer

🇮🇹 Italy·2 Manufacturers

DOCTOPHARMA TIL.K.GIOKARIS & Co

Importer

1 Manufacturer

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR

VERACITY IVD KIT REAGENTS for 48 samples

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·MEDICOVER GENETICS LIMITED·1 device

1434-MDD-070/2021

Certificate

MDD Annex II (excluding section 4)·MEDI J Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

Welch Allyn, Inc.

FDA UDI

WELCH ALLYN, INC.·00732094118841·Welch Allyn Connex Integrated Wall System with ...