Vanguard XP Knee System

FDA registration

Zimmer Biomet G.K.·4 products·🇯🇵 Japan

Signature Planner

FDA registration

Materialise Ukraine, Rep. office·4 products·🇺🇦 Ukraine

Zimmer Knee Joint Replacement Prostheses

FDA registration

Cosmed Group, Inc., d/b/a Cosmed of NJ·4 products·🇺🇸 United States

Materialise Knee Guide System

FDA registration

MATERIALISE N.V.·4 products·🇧🇪 Belgium

Zimmer Patient Specific Instruments

FDA registration

Materialise Ukraine, Rep. office·4 products·🇺🇦 Ukraine

GT990402 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL GT980201 ELECTRONIC THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, Mu

EB Neuro S.p.A.

Importer

🇮🇹 Italy·6 Manufacturers

Loopamp(TM) PURE DNA Extraction Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·EIKEN CHEMICAL CO., LTD.·1 device

OC-Auto Sampling Bottle 3

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·EIKEN CHEMICAL CO., LTD.·8 devices

OC-Light™ S FIT Sampling Bottles

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·EIKEN CHEMICAL CO., LTD.·1 device

Loopamp™ MTBC Detection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·1 device

OC-FCa Reagent Family

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·EIKEN CHEMICAL CO., LTD.·6 devices

OC-SENSOR Reagent Family

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·14 devices

OC-Light™ S FIT Test Strips

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·1 device

Loopamp™ Malaria Pv Detection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·1 device

Loopamp™ Malaria Pf Detection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·1 device

Loopamp™ Malaria Pan Detection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·EIKEN CHEMICAL CO., LTD.·2 devices

OC Equipment Family

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·EIKEN CHEMICAL CO., LTD.·2 devices