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

MTS Medizintechnische Servicegesellschaft mbH

System producer

🇩🇪 Germany

Bioptimal International Pte. Ltd.

System producer

🇸🇬 Singapore

Smartz Operations Pty Ltd

System producer

🇦🇺 Australia

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

Compliance Management Solutions Europe LTD

Importer

🇧🇬 Bulgaria·4 Manufacturers

IVDD 21 061 0128

Certificate

IVDD Annex IV Section 4·MP Biomedicals Asia Pacific Pte Ltd·bqs. s.r.o.·2 Basic UDI-DIs

IVDD 21 062 0130

Certificate

IVDD Annex IV Section 4·MP Biomedicals Asia Pacific Pte Ltd·bqs. s.r.o.·2 Basic UDI-DIs

IVDD 21 060 0126

Certificate

IVDD Annex IV Section 4·MP Biomedicals Asia Pacific Pte Ltd·bqs. s.r.o.·2 Basic UDI-DIs

V7 068207 0046

Certificate

IVDD Annex IV Section 4·MP Biomedicals Asia Pacific Pte Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

Fairmont Medical Products Pty Ltd

System producer

🇦🇺 Australia

Trajan Scientific Australia Pty Ltd

System producer

🇦🇺 Australia

Vibrator for women:S-V58B,TE-07-689RW,VS-07-715PU,DD-07-187PR, SQ-V36CHP,S-D80C,SQ-V37C,S-E32B,WE-07-686RE

FDA registration

UC Global Trade INC.·1 product·🇺🇸 United States

Medzorg Nederland BV

Importer

🇳🇱 Netherlands·1 Manufacturer