11 results
·
10ms
·
Sources: EU EUDAMED, US FDA
Lunit INSIGHT CXR
Device
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·On the market·20 countries
Lunit INSIGHT CXR
Device
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·On the market·30 countries
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
Lunit INSIGHT CXR
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Lunit Inc.·2 devices
Infrared Ear Thermometer
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Radiant Innovation Inc.·17 devices
HCV ANTIBODY -RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·On the market
HBSAG - RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·On the market
HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·1 device
HBsAg Hepatitis B Surface Antigen 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
No. 11 0497 QS/NB
Certificate
IVDD Annex IV (excluding sections 4, 6)·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs
No. 11 0498 CN/NB
Certificate
IVDD Annex IV Section 4·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs