SMEDTEC OÜ

Authorized representative

🇪🇪 Estonia·1 Manufacturer

Radioimmunoassay, Phenobarbital

FDA classification

FDA Class 2 ·Radioimmunoassay, Phenobarbital

Reamer, Pulp Canal, Endodontic

FDA classification

FDA Class 1 ·Reamer, Pulp Canal, Endodontic

Cancer Antigen 125(CLIA)、CA125 Calibrators

Basic UDI-DI

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

VID83-

Basic UDI-DI

EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device

System, Peritoneal, Automatic Delivery, Exempt

FDA classification

FDA Class 2 ·System, Peritoneal, Automatic Delivery, Exempt

Catheter, Peritoneal Dialysis, Single Use, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal Dialysis, Single Use, Exempt

Medline International France

Authorized representative

🇫🇷 France·3 Manufacturers

Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper)

FDA registration

SEWON MEDIX, INC.·1 product·🇰🇷 South Korea

Cook Ireland

Importer

🇮🇪 Ireland·3 Manufacturers

CF1210A, CF1211A, CF1212A, CF1213A, CF1201B, CF1202B, CF1203B, CF1204B, CF1205B, CF1207B, CF1208B, CF1209B, CF1210B,

FDA registration

SHENZHEN GREATMADE TECH LIMITED·1 product·🇨🇳 China

Technomedics Norge AS

Importer

🇳🇴 Norway·12 Manufacturers

Medline International B.V.

Importer

🇳🇱 Netherlands·4 Manufacturers

Cook Medical Europe Ltd

Importer

🇮🇪 Ireland·9 Manufacturers

Hofmeester Dental B.V.

Importer

🇳🇱 Netherlands·16 Manufacturers

American Dental Systems GmbH

Importer

🇩🇪 Germany·37 Manufacturers

Plandent Oy

Importer

🇫🇮 Finland·43 Manufacturers

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices