6,159 results · 44ms · Sources: EU EUDAMED, US FDA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM

Stopler-QRS groep

Importer
🇳🇱 Netherlands·18 Manufacturers

CL0943010004

Certificate
MDD Annex II (excluding section 4)·Dongguan ZSR Biomedical Technology Company Limited·TÜV SÜD Product Service GmbH·16 Basic UDI-DIs

CL 094301 0004

Certificate
MDD Annex II (excluding section 4)·Dongguan ZSR Biomedical Technology Company Limited·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

Spirit

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·1 device

Body Shape

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·1 device

Prime

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Top Engineering Sarl·1 device

Skin Shape

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Top Engineering Sarl·1 device

Forte - 718

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Top Engineering Sarl·1 device

Optima

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·1 device

Spirit

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·1 device

Top Epil Classic

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Top Engineering Sarl·1 device

Extra

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·1 device

Extra

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·1 device

Prosthetic Component

Basic UDI-DI
EU MDD · Eu Md Class 2a ·SWEDEN & MARTINA S.P.A.·1 device

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Triolab AB

Importer
🇸🇪 Sweden·5 Manufacturers

M-PH-5T-15

FDA registration
APK TECHNOLOGY CO., LTD·1 product·🇨🇳 China

Triolab AS

Importer
🇳🇴 Norway·5 Manufacturers

General Purpose Reagent

FDA classification
FDA Class 1 ·General Purpose Reagent