Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·IsoMed Infusion System

Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

FDA classification

FDA Class 2 ·Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

Antiserum, Digitoxin

FDA classification

FDA Class 2 ·Antiserum, Digitoxin

Preparer, Root Canal Endodontic

FDA classification

FDA Class 1 ·Preparer, Root Canal Endodontic

geneMAP MPL W515A/L/K/R Mutation Detection Kit, 25T

Basic UDI-DI

EU IVDD · Eu Ivd General ·GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ·1 device

Computerized Cognitive Assessment Aid, Exempt

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid, Exempt

OneApp

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·1 device

Pierced Ear/Entry Cleaning Tray

FDA classification

FDA Class 1 ·Pierced Ear/Entry Cleaning Tray

Enamel Plus Temp ®

FDA UDI

MICERIUM SPA·EMICTEMP1NOF1·ENAMEL PLUS TEMP INTRODUCTORY KIT - 1 TEMP1-CLE...

OFTALMEDICA SRL

Importer

🇮🇹 Italy·13 Manufacturers

W.M.BLOSS, S.A

Importer

🇪🇸 Spain·20 Manufacturers

SANOTEK

Importer

🇫🇷 France·15 Manufacturers

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices