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

HYGITECH

FDA UDI

HYGITECH·03615140005197·Surgeon kit HYGITECH Reference: HY-0421 The SUR...

Curaplex

FDA UDI

BOUND TREE MEDICAL, LLC·00815277020602·BTM Light Weight Monitoring Module / ECG, RESP,...

Device, Pasteurization, Hot Water

FDA classification

FDA Class 2 ·Device, Pasteurization, Hot Water

Bottle, Hot/Cold Water

FDA classification

FDA Class 1 ·Bottle, Hot/Cold Water

Hemopexin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Hemopexin, Fitc, Antigen, Antiserum, Control

Stethoscope, Esophageal, With Electrical Conductors

FDA classification

FDA Class 2 ·Stethoscope, Esophageal, With Electrical Conductors

BZT-TCP Certification GmbH

Authorized representative

🇩🇪 Germany·2 Manufacturers

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D

Emergency Medical Products

FDA UDI

EMERGENCY MEDICAL PRODUCTS, INC.·00851772007120·O2 To Go Pro Oxygen/Trauma Kit

Emergency Medical Products

FDA UDI

EMERGENCY MEDICAL PRODUCTS, INC.·00851772007298·Contents for O2 To Go Pro Oxygen/Trauma Kit

HYGITECH

FDA UDI

HYGITECH·03615140005272·Paro kit HYGITECH Reference: HY-08811 The PARO ...

Pack, Hot Or Cold, Disposable

FDA classification

FDA Class 1 ·Pack, Hot Or Cold, Disposable

Pack, Hot Or Cold, Reusable

FDA classification

FDA Class 1 ·Pack, Hot Or Cold, Reusable

HYGITECH

FDA UDI

HYGITECH·03615140005210·Implanwear kit HYGITECH Reference: HY-08511 The...

Sodium electrode

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device

HMT Medizintechnik GmbH

System producer

🇩🇪 Germany

Pack, Hot Or Cold, Water Circulating

FDA classification

FDA Class 2 ·Pack, Hot Or Cold, Water Circulating

Curaplex

FDA UDI

BOUND TREE MEDICAL, LLC·00815277020664·BTM Light Weight Monitoring Defib Module