Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·INVIVE CRT PS, INTUA CRT PS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System

ENERPEEL NECK

Basic UDI-DI

EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

FDA classification

FDA Class 2 ·Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

Gutta-Percha

FDA classification

FDA Class 1 ·Gutta-Percha

Adaptor, Fistula

FDA classification

FDA Class 2 ·Adaptor, Fistula

DZ 2468875-1

Certificate

MDR QA·ALLMED MEDICAL TEXTILE CO.,LTD (VIET NAM)·TÜV Rheinland LGA Products GmbH

KM-Enke GmbH

Importer

🇩🇪 Germany

KM Innovations B.V.

Importer

🇳🇱 Netherlands·1 Manufacturer

ADYTON s.r.o., (angl. Ltd, něm. GmbH, franc. S.R.L.A.)

Importer

🇨🇿 Czechia

KM Optics Denmark ApS

Importer

🇩🇰 Denmark·6 Manufacturers

Llins Service & Consulting GmbH

Authorized representative

🇩🇪 Germany·39 Manufacturers·556 Devices

Rolko FIXATION CLAMP KL-STH-CL28

FDA registration

Rolko North America, Inc.·1 product·🇺🇸 United States

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices