23 results
·
9ms
·
Sources: EU EUDAMED, US FDA
Calpro AS
Manufacturer
🇳🇴 Norway·4 Basic UDI-DIs·4 Devices·Eurofins Electric & Electronics Finland Oy
CIGA Healthcare Ltd
Manufacturer
1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Hangzhou Realy Tech Co.,Ltd.
Manufacturer
🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.
TODA PHARMA
Manufacturer
🇫🇷 France·26 Basic UDI-DIs·27 Devices·BSI Group The Netherlands B.V.
CalproSmart Self-Test
Device
EU IVDD
·
Eu Ivd Self Testing
·Calpro AS·On the market·15 countries
Sainsbury's Health Matters 2 Pregnancy
Device
EU IVDD
·
Eu Ivd Self Testing
·CIGA Healthcare Ltd·On the market
SARS-Cov-2&Influenza A/B Combo Rapid Test Cassette (swab)
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·On the market
Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·On the market
Novel Coronavirus(SARS-Cov-2)Antigen Rapid Test Device(saliva)
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·On the market
Calprosmart Self-Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Calpro AS·1 device
Sainbury's Pregnancy Midstream Twin
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·CIGA Healthcare Ltd·1 device
K751416D
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·1 device
K601416D
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·1 device
Novel Coronavirus(SARS-Cov-2)Antigen Rapid Test Device(saliva)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Realy Tech Co.,Ltd.·1 device
Toda Autotest Nasal Covid-19
Device
EU IVDD
·
Eu Ivd Self Testing
·TODA PHARMA·On the market
BSI Group The Netherlands B.V.
Notified body
🇳🇱 Netherlands·376 Manufacturers·26587 Basic UDI-DIs
C-02-1206-801-22
Certificate
IVDD Annex III Section 6·Calpro AS·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI
1434-IVDD-188/2022
Certificate
IVDD Annex III Section 6·CIGA Healthcare Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
CeCert/100/W/E.1
Certificate
IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/025/W/E.1
Certificate
IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI