10,000 results · 17ms · Sources: EU EUDAMED, US FDA

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IBT

Device
EU MDR · Eu Md Class 1 ·Hangzhou SHINING3D Dental Technology Co., Ltd. ·On the market·2 countries

KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)

FDA 510(k)
FDA Class 2 ·Anesthesiology

cuff

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Contec Medical Systems Co., Ltd.·1 device

Strep A Rapid Test Device (Throat Swab)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

Strep A Rapid Test Strip (Throat Swab)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

G1 081681 0021

Certificate
MDD Annex II (excluding section 4)·Shanghai INT Medical Instruments Co., Ltd.·TÜV SÜD Product Service GmbH·16 Basic UDI-DIs

CL 081681 0027

Certificate
MDD Annex II (excluding section 4)·Shanghai INT Medical Instruments Co., Ltd.·TÜV SÜD Product Service GmbH·16 Basic UDI-DIs

Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Genrui Biotech Inc.·1 device

Methadone (MTD) Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Beijing Jinwofu Bioengineering Technology Co., Ltd.·1 device

MAGICL AMH (CLIA)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Getein Biotech, Inc.·1 device

Transfer pipette( Capillary pipette/ Glass capillary tube/ Fixed volume pipette/ Capillary blood collector)

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Jiangsu Kehua Medical Instrument Technology Co., Ltd.·2 devices

Pre-filled tube

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Jiangsu Kehua Medical Instrument Technology Co., Ltd.·2 devices

saliva collection and preservation system

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu KangJian Medical Apparatus Co., Ltd.·1 device

virus collection and preservation system

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu KangJian Medical Apparatus Co., Ltd.·1 device

LH

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Hubei MEIBAO Biotechnology Co., Ltd·4 devices

DBS CoreShell-Dried Blood Spot Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Sinopharm Allmed (Hubei) Medical Products Co., Ltd.·2 devices

Fetal Aneuploidies (Trisomy 21, Trisomy18 and Trisomy13) Detection Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·CapitalBio Genomics Co.,Ltd.·1 device

Hemoglobin Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device

Luminescence Buffer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Accucise Diagnostics Inc.·3 devices

Alkaline Clean

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Accucise Diagnostics Inc.·3 devices