MRA Q00068

Certificate

MDD Annex II (excluding section 4)·Ellex Medical Pty Ltd·THERAPEUTIC GOODS ADMINISTRATION·15 Basic UDI-DIs

CE 603229

Certificate

MDD Annex II (excluding section 4)·Biobot Surgical Pte Ltd·BSI Group The Netherlands B.V.·3 Basic UDI-DIs

CE694938

Certificate

MDD Annex V·Kesem Health Pty Ltd·BSI Group The Netherlands B.V.·1 Basic UDI-DI

Power Wheelchair Magic Mobility

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Red Milawa Pty Ltd T/A Magic Mobility·4 devices

Mechanical Tools

Basic UDI-DI

EU MDR · Eu Md Class 1 ·PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·3 devices

Mechanical Tools

Basic UDI-DI

EU MDR · Eu Md Class 1 ·PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·4 devices

OCTAVIUS Phantoms

Basic UDI-DI

EU MDR · Eu Md Class 1 ·PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·7 devices

Radiotherapy Phantoms/Test Objects

Basic UDI-DI

EU MDR · Eu Md Class 1 ·PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·21 devices

Scan Gauge Kit

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Implant solutions Pty Ltd (T/A Osteon Medical)·31 devices

Dosimetry Cables

Basic UDI-DI

EU MDR · Eu Md Class 1 ·PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·46 devices

Manual Water Phantoms

Basic UDI-DI

EU MDR · Eu Md Class 1 ·PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·7 devices

Manual Water Phantoms

Basic UDI-DI

EU MDR · Eu Md Class 1 ·PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·3 devices

Bioptimal International Pte. Ltd.

System producer

🇸🇬 Singapore

Smartz Operations Pty Ltd

System producer

🇦🇺 Australia

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

HL 20744998-1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Vela Operations Singapore Pte. Ltd.·TÜV Rheinland LGA Products GmbH·3 Basic UDI-DIs

HL 2074998-1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Vela Operations Singapore Pte. Ltd.·TÜV Rheinland LGA Products GmbH·7 Basic UDI-DIs

IL 2074998-2

Certificate

IVDD Annex IV Section 4·Vela Operations Singapore Pte. Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

IL 2074998-1

Certificate

IVDD Annex IV Section 4·Vela Operations Singapore Pte. Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

HD-2147677

Certificate

MDD Annex II (excluding section 4)·Advanced Ophthalmic Innovations Pte. Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI