21 results · 25ms · Sources: EU EUDAMED, US FDA

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AMD Hubei Inc.

FDA registration
AMD Hubei Inc.·3 products·🇨🇳 China

Curatia Medical Limited

Manufacturer
🇨🇳 China

GE HUALUN MEDICAL SYSTEMS CO. Ltd

Manufacturer
🇨🇳 China·7 Basic UDI-DIs·7 Devices·GMED SAS

HIV 1 / 2 - RT & POC

Device
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

AMD-RS-AE0001-L

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Shenzhen Amydi-med Electrics Tech Co.,Ltd·1 device

Surgical Gowns

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Sichuan Shuzhan New Materials Co., Ltd·1 device

MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY

Device
EU MDD · Eu Md Class 2b ·GE HUALUN MEDICAL SYSTEMS CO. Ltd·On the market·32 countries

Sharay Anti-GAD IgG (CLIA)

Basic UDI-DI
EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·1 device

BioCLIA Autoimmune Control Set, GAD

Basic UDI-DI
EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·1 device

BioCLIA Autoimmune Calibrator Set, GAD

Basic UDI-DI
EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·1 device

BioCLIA Autoimmune Reagent Kit, GAD

Basic UDI-DI
EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·1 device

BioCLIA Autoimmune Reagent Kit, GAD

Basic UDI-DI
EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·1 device

PCR-CE DMD gene Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biofast Biotechnology Co., Ltd.·1 device

PCR-CE DMD gene Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biofast Biotechnology Co., Ltd.·1 device

Abon Biopharm(Hangzhou) Co., Ltd

Manufacturer
🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS

Glucose Kit (GOD-POD Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

XR6000

Basic UDI-DI
EU MDD · Eu Md Class 2b ·GE HUALUN MEDICAL SYSTEMS CO. Ltd·1 device

7846

Certificate
MDD Annex II (excluding section 4)·GE HUALUN MEDICAL SYSTEMS CO. Ltd·GMED SAS·1 Basic UDI-DI

N°20317

Certificate
IVDD Annex IV Section 4·Abon Biopharm(Hangzhou) Co., Ltd·GMED SAS·1 Basic UDI-DI