THERMOFX MESH

FDA 510(k)

FDA Class 2 ·Dental

FKG SWISS ENDO IBERIA,S.L.

Importer

🇪🇸 Spain

FBI Medizintechnik GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

FI-LOG

Importer

🇫🇷 France

MODELLING LIQUID

Basic UDI-DI

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

Xpert® Nasal Sample Collection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Cepheid·1 device

Carrier, Amalgam, Operative

FDA classification

FDA Class 1 ·Carrier, Amalgam, Operative

Handpiece, Water-Powered

FDA classification

FDA Class 1 ·Handpiece, Water-Powered

Indicator, Alumina Fluorescent, Tlc

FDA classification

FDA Class 1 ·Indicator, Alumina Fluorescent, Tlc

PureMDR GmbH

Authorized representative

🇩🇪 Germany·9 Manufacturers·21 Devices

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

Maggots, Medical

FDA classification

FDA Unclassified ·Maggots, Medical

Seating

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ki Mobility LLC·11 devices

Manual Wheelchair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ki Mobility LLC·18 devices

Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

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

FDA Pre-Market Approval

MediBeacon® Transdermal GFR Measurement System (TGFR)