Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor Saline-Filled Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED BREAST IMPLANTS

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)

FDA registration

EUROIMMUN US INC.·5 products·🇺🇸 United States

Micro Camera

FDA registration

HEBUMEDICAL GMBH·5 products·🇩🇪 Germany

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)

FDA registration

EUROIMMUN Medizinische Labordiagnostika AG·5 products·🇩🇪 Germany

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)

FDA registration

EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·5 products·🇩🇪 Germany

IBM Ireland

Importer

🇮🇪 Ireland·1 Manufacturer

MED 31220

Certificate

MDD Annex II (excluding section 4)·DBM SRL·KIWA CERMET ITALIA S.P.A.·3 Basic UDI-DIs

27671

Certificate

MDD Annex VI·FIM Médical·GMED SAS·2 Basic UDI-DIs

Phlecs full body blue

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Phlecs B.V.·1 device

Lifemotion Console

Basic UDI-DI

EU MDR · Eu Md Class 2b ·CHINABRIDGE (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.·13 devices

Disposable ECMO Set

Basic UDI-DI

EU MDR · Eu Md Class 2a ·CHINABRIDGE (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.·3 devices

Disposable Membrane Oxygenator

Basic UDI-DI

EU MDR · Eu Md Class 2a ·CHINABRIDGE (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.·2 devices

Disposable Centrifugal Pump Head

Basic UDI-DI

EU MDR · Eu Md Class 2a ·CHINABRIDGE (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.·1 device

HBM Medical

Authorized representative

🇮🇪 Ireland·1 Manufacturer·23 Devices

FBI Medizintechnik GmbH

Importer

🇩🇪 Germany·1 Manufacturer

13354-2018-CE-RGC-NA

Certificate

MDD Annex II (excluding section 4)·EBM Technologies Inc.·DNV Product Assurance AS·2 Basic UDI-DIs

Ultrasonic cleaner

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Shenzhen Codyson Electrical Co., Ltd·1 device

Ultrasonic cleaner

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Shenzhen Codyson Electrical Co., Ltd·1 device