No.G1 101873 0002

Certificate

MDD Annex II (excluding section 4)·Beijing ADSS Development Co., Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY XL DR MODEL 5376 PULSE GENERATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY SR MODEL 5172 PULSE GENERATOR

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY PULSE GENERATOR MODEL DR 5370

AB Electronics Adam Bieniek

Importer

🇵🇱 Poland·1 Manufacturer

SELF-RETAINING RETRACTORS MAYO-ADAMS (BLUNT) 2X2 TEETH 165MM

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Daddy D Pro·1 device

TNP/MDD/0270/4880/2019

Certificate

MDD Annex II (excluding section 4)·MEDICAL DEVICES WORKS "UNIMED" ADAM ANDRUSZCZAK·TUV NORD Polska Sp. z o.o·7 Basic UDI-DIs

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY PACEMAKERS

DSM Biomedical B.V.

Authorized representative

🇳🇱 Netherlands·1 Manufacturer·48 Devices

Adamant Health Ltd

System producer

🇫🇮 Finland

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A

Alarm, Leakage Current, Portable

FDA classification

FDA Class 1 ·Alarm, Leakage Current, Portable

Kirschner Blade

FDA registration

MARINA MEDICAL INSTRUMENTS, INC.·1 product·🇺🇸 United States

552587

Certificate

MDD Annex II Section 4·DSM Biomedical·BSI Group The Netherlands B.V.·1 Basic UDI-DI

583404

Certificate

MDD Annex II Section 4·DSM Biomedical·BSI Group The Netherlands B.V.·9 Basic UDI-DIs

558748

Certificate

MDD Annex II Section 4·DSM Biomedical·BSI Group The Netherlands B.V.·24 Basic UDI-DIs

686790

Certificate

MDD Annex II Section 4·DSM Biomedical·BSI Group The Netherlands B.V.·8 Basic UDI-DIs

552477

Certificate

MDD Annex II Section 4·DSM Biomedical·BSI Group The Netherlands B.V.·6 Basic UDI-DIs