Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP 2000 SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN SYSTEM

OFERIA CONSULTING

Authorized representative

🇫🇷 France·2 Manufacturers

Bayonet Forceps GK2 Medium 31-5162

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Charmant Inc.·1 device

GKB LAB

Importer

🇫🇷 France

GK-20

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·MVZ Medizinische Labore Dessau Kassel GmbH·4 devices

GQ QUATTRO CLEAN

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ALPRO MEDICAL GMBH·1 device

Fully-Automatic Chemiluminescence Immunoassay Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Xiamen United Medical Instruments Co., Ltd.·6 devices

LAC

Basic UDI-DI

EU MDR · Eu Md Class 1 ·HUZUR DENTAL TIBBİ ÜRÜNLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ·2 devices

MultiSure GK glucose control solution

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Apex Biotechnology Corp.·1 device

MultiSure GK ketone control solution

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Apex Biotechnology Corp.·1 device

GKO ECOBLAST SERVICES SRL

Importer

🇷🇴 Romania

Bayonet Forceps GK Long 31-5154

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Charmant Inc.·1 device

Bayonet Forceps GK Medium 31-5153

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Charmant Inc.·1 device

MultiSure GK blood glucose test strips

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Apex Biotechnology Corp.·1 device

MultiSure GK blood ketone test strips

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Apex Biotechnology Corp.·1 device

MultiSure GK Blood Glucose and Ketone Monitoring System

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Apex Biotechnology Corp.·1 device

Antiserum, Digitoxin

FDA classification

FDA Class 2 ·Antiserum, Digitoxin

Preparer, Root Canal Endodontic

FDA classification

FDA Class 1 ·Preparer, Root Canal Endodontic

GK Handelsgesellschaft mbH

Importer

🇩🇪 Germany·1 Manufacturer