23 0517 QR/NB

Certificate

MDR QMS·GAMA GROUP a.s.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

23 0493 QR/NB

Certificate

MDR QMS·Flídr medical s.r.o.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

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

200234 QS/NB

Certificate

MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·4 Basic UDI-DIs

200234QS/NB

Certificate

MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

21 0212 QS/NB

Certificate

MDD Annex II (excluding section 4)·M.I.Tech Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·12 Basic UDI-DIs

190004 QS/NB

Certificate

MDD Annex II (excluding section 4)·ICZ.HEA a.s.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

170222 QS/NB

Certificate

MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

GRUPO R QUERALTÓ S.A.

Importer

🇪🇸 Spain·21 Manufacturers

INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Notified body

🇨🇿 Czechia·16 Manufacturers·135 Basic UDI-DIs

COBAS INTEGRA SYSTEM

FDA registration

ROCHE DIAGNOSTICS GMBH·62 products·🇩🇪 Germany

COBAS INTEGRA SYSTEM

FDA registration

ROCHE DIAGNOSTICS INTERNATIONAL LTD.·62 products·🇨🇭 Switzerland

COBAS INTEGRA SYSTEM

FDA registration

ROCHE DIAGNOSTICS GMBH·62 products·🇩🇪 Germany

ANALYZER, CHEMISTRY

FDA registration

Diamond Diagnostics Inc.·62 products·🇭🇺 Hungary

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS GMBH·78 products·🇩🇪 Germany

Aptio Automation System

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·76 products·🇺🇸 United States

cobas 8000 cobas ISE MODULE [DOUBLE]

FDA registration

ROCHE DIAGNOSTICS GMBH·78 products·🇩🇪 Germany

Aptio Automation System

FDA registration

INPECO SA·76 products·🇨🇭 Switzerland

Analyzer

FDA registration

Diamond Diagnostics Inc.·78 products·🇭🇺 Hungary