34 results
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16ms
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Sources: EU EUDAMED, US FDA
Nucleix
Manufacturer
🇮🇱 Israel
Sanway Gene Tech. Inc.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·On the market·3 countries
1434-IVDD-198/2022
Certificate
IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
1434-IVDD-199/2022
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·1 device
Healcerion Co., Ltd.
Manufacturer
🇰🇷 South Korea·3 Basic UDI-DIs·3 Devices·DNV Product Assurance AS and DNV Product Assurance AS
ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS
Device
EU MDD
·
Eu Md Class 2b
·Woo Young Medical Co., Ltd.·On the market·9 countries
MDT Diamond Coated Dental Burs
Device
EU MDR
·
Eu Md Class 2a
·MDT Micro Diamond Technologies Ltd.·On the market·1 country
Evermine50™
Device
EU MDD
·
Eu Md Class 3
·Meril Life Sciences Pvt. Ltd.·On the market·4 countries
CANCER ANTIGEN 50
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
ADRENOCORTIOTROPIC HORMONE
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS
Device
EU MDD
·
Eu Md Class 2b
·Woo Young Medical Co., Ltd.·On the market·9 countries
TUBULAR ELASTIC NET FIX-2 EX-25M
Device
EU MDR
·
Eu Md Class 1
·Dynamic Techno Medicals Pvt Ltd·Not intended for eu market
TUBULAR ELASTIC NET FIX-3 EX-25M
Device
EU MDR
·
Eu Md Class 1
·Dynamic Techno Medicals Pvt Ltd·Not intended for eu market
TUBULAR ELASTIC NET FIX-1-EX-25M
Device
EU MDR
·
Eu Md Class 1
·Dynamic Techno Medicals Pvt Ltd·Not intended for eu market
EASYNET PRECUT 6CM X 75CM
Device
EU MDR
·
Eu Md Class 1
·Dynamic Techno Medicals Pvt Ltd·Not intended for eu market
EASYNET PRECUT 5CM X 75CM
Device
EU MDR
·
Eu Md Class 1
·Dynamic Techno Medicals Pvt Ltd·Not intended for eu market
EASYNET PRECUT 4CM X 75CM
Device
EU MDR
·
Eu Md Class 1
·Dynamic Techno Medicals Pvt Ltd·Not intended for eu market
EASYNET PRECUT 3CM X 75CM
Device
EU MDR
·
Eu Md Class 1
·Dynamic Techno Medicals Pvt Ltd·Not intended for eu market