Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

FDA classification

FDA Class 2 ·Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

MTS Systemtechnik s.r.o.

Authorized representative

🇨🇿 Czechia·2 Manufacturers·21 Devices

PHS Medical GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

MTS Medizintechnische Servicegesellschaft mbH

Importer

🇩🇪 Germany·1 Manufacturer

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

FDA classification

FDA Class 2 ·Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

myONE S66/47E

FDA UDI

GLOBAL PROTECTION CORP.·00726893511569·36 Lubricated Latex Condoms

QT ECG

FDA UDI

Qt Medical, Inc.·04719872981503·The QT ECG system is a hand-held, cordless 12-l...

Tube, Bronchial (W/Wo Connector)

FDA classification

FDA Class 2 ·Tube, Bronchial (W/Wo Connector)

Sucker, Cardiotomy Return, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Zeus The Bionic Hand

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Aether Biomedical Spółka z ograniczoną odpowiedzialnością·1 device

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA classification

FDA Class 3 ·Drug-Eluting Peripheral Transluminal Angioplasty Catheter

MED-002485-01

Certificate

MDD Annex II Section 4·Burnshield (Pty) Ltd·DNV Product Assurance AS·36 Basic UDI-DIs

546003 MR5

Certificate

MDD Annex V·Livac Pty Ltd·DQS Medizinprodukte GmbH·2 Basic UDI-DIs

V1 003496 007

Certificate

IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

V1 003469 0007

Certificate

IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

170775883

Certificate

MDD Annex II (excluding section 4)·Navbit Pty Ltd·DQS Medizinprodukte GmbH·1 Basic UDI-DI

541616 MR2

Certificate

MDD Annex II (excluding section 4)·Navbit Pty Ltd·DQS Medizinprodukte GmbH·1 Basic UDI-DI

G2S 105080 0003

Certificate

MDD Annex V·Qlicksmart Pty Ltd·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

V1 003496 0007

Certificate

IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·24 Basic UDI-DIs

G1 096382 0009

Certificate

MDD Annex II (excluding section 4)·Ozdent Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI