Rapid Automatic Washer-Disinfector

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Shinva Medical Instrument Co., Ltd.·5 devices

Dental Unit

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Shinva Medical Instrument Co., Ltd.·2 devices

Hydrogen Peroxide Cartridge

Basic UDI-DI

EU MDR · Eu Md Class 2b ·Shinva Medical Instrument Co., Ltd.·3 devices

Ultrasonic Washer

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Shinva Medical Instrument Co., Ltd.·10 devices

Flexible Endoscope Washer-disinfector

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Shinva Medical Instrument Co., Ltd.·6 devices

Flexible Endoscope Storage Cabinet

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Shinva Medical Instrument Co., Ltd.·7 devices

H2O2 Low Temperature Plasma Sterilizer

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Shinva Medical Instrument Co., Ltd.·6 devices

Pulse Vacuum Sterilizer

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Shinva Medical Instrument Co., Ltd.·6 devices

Autoclave

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Shinva Medical Instrument Co., Ltd.·1 device

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA classification

FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

FDA classification

FDA Class 2 ·Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

FDA classification

FDA Class 2 ·Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

FDA classification

FDA Class 2 ·Influenza A Virus Subtype Differentiation Nucleic Acid Assay

Thermocycler, Generic

FDA classification

FDA Class 1 ·Thermocycler, Generic

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

3901646CE01

Certificate

MDD Annex II (excluding section 4)·CathWorks Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI

7406GB410210510A

Certificate

MDD Annex II (excluding section 4)·EyeYon Medical Ltd.·DNV MEDCERT GmbH·2 Basic UDI-DIs

2125546CE01

Certificate

MDD Annex II (excluding section 4)·IOPtima Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI

170222 QS/NB

Certificate

MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

G1 055809 0022

Certificate

MDD Annex II (excluding section 4)·Gentec (Shanghai) Corporation·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs