ANA Screen FIA Kit

Device

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

ANA Screen FIA Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

FI20/00010

Certificate

MDD Annex II (excluding section 4)·Leltek Inc.·DNV Product Assurance AS·2 Basic UDI-DIs

FI2000010

Certificate

MDD Annex II Section 4·Leltek Inc.·SGS FIMKO OY·1 Basic UDI-DI

TW19/20030

Certificate

MDD Annex II (excluding section 4)·Somnics, Inc.·SGS Belgium NV·2 Basic UDI-DIs

41315215

Certificate

MDD Annex II (excluding section 4)·Nova Eye, Inc.·INTERTEK SEMKO AB·2 Basic UDI-DIs

160841CE01

Certificate

MDD Annex II (excluding section 4)·NP Medical, Inc.·DEKRA Certification B.V.·1 Basic UDI-DI

M.2021.106.14179

Certificate

MDD Annex II (excluding section 4)·Simedice Biotechnologies Inc.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·1 Basic UDI-DI

2005 12 0495 CT

Certificate

IVDD Annex IV (excluding sections 4, 6)·MedMira Laboratories Inc.·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS·6 Basic UDI-DIs

FI20/07011

Certificate

MDD Annex II (excluding section 4)·QT Medical, Inc.·SGS FIMKO OY·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

9727-2017-CE-RGC-NA-PS

Certificate

MDD Annex V·TRONJEN MEDICAL TECHNOLOGY INC.·DNV Product Assurance AS·5 Basic UDI-DIs

CE697225

Certificate

MDD Annex II (excluding section 4)·ENDRA Life Sciences, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

26445

Certificate

MDD Annex II (excluding section 4)·Synergy Spine Solutions Inc.·GMED SAS·12 Basic UDI-DIs