9,395 results · 48ms · Sources: EU EUDAMED, US FDA

84587CE01

Certificate
MDD Annex II (excluding section 4)·HTL-Strefa S.A.·TÜV Rheinland LGA Products GmbH·7 Basic UDI-DIs

FR19/81843455

Certificate
MDD Annex II (excluding section 4)·THT BIO-SCIENCE·SGS Belgium NV·20 Basic UDI-DIs

FR19:81843455

Certificate
MDD Annex II (excluding section 4)·THT BIO-SCIENCE·SGS Belgium NV·1 Basic UDI-DI

Hypertension Multi Control

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

TT

Basic UDI-DI
EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

Reusable cold/hot gel compress

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd·10 devices

Rubicon Technical Limited

Authorized representative
🇳🇱 Netherlands·3 Manufacturers

Ecarin Clotting Time

FDA classification
Ecarin Clotting Time

Sterylab (CC) - MLC-Multicore

FDA registration
STERIS SPA·2 products·🇮🇹 Italy

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·IFORIA/ILESTO/INVENTRA/IPERIA/ITREVIA 5/7 DR-T/VR-T/VR-T DX, & VARIOUS LUMAX ICDS; IFORIA/ILESTO/IPERIA/ITREVIA 5/7 HF-T

Vivo 45 LS

FDA registration
BREAS MEDICAL AB·5 products·🇸🇪 Sweden

Vivo 45LS

FDA registration
BREAS MEDICAL, INC.·5 products·🇺🇸 United States

Vivo 45 LS

FDA registration
BREAS MEDICAL, INC.·5 products·🇺🇸 United States

Vivo 45 LS

FDA registration
BREAS MEDICAL AB·5 products·🇸🇪 Sweden

Rongeur, Cystoscopic, Hot

FDA classification
FDA Class 2 ·Rongeur, Cystoscopic, Hot

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T

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

FDA Pre-Market Approval
FDA Class 3 ·Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP

Device, Pasteurization, Hot Water

FDA classification
FDA Class 2 ·Device, Pasteurization, Hot Water