23 results · 9ms · Sources: EU EUDAMED, US FDA

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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