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Sources: EU EUDAMED, US FDA
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543722 MR2
Certificate
MDD Annex II (excluding section 4)·Adhe-Els SA.·DQS Medizinprodukte GmbH·141 Basic UDI-DIs
543722 MR2
Certificate
MDD Annex II (excluding section 4)·Adhe-Els SA.·DQS Medizinprodukte GmbH·7 Basic UDI-DIs
543722MR2
Certificate
MDD Annex II (excluding section 4)·Adhe-Els SA.·DQS Medizinprodukte GmbH·19 Basic UDI-DIs
CN23/00006256
Certificate
MDR QMS·4L Health Co., Ltd·SGS Belgium NV
CN19/41043
Certificate
MDD Annex II (excluding section 4)·4L Health Co., Ltd·SGS Belgium NV·1 Basic UDI-DI
DZ 2048293-1
Certificate
MDR QA·Jiangxi 3L Medical Products Group Co., Ltd.·TÜV Rheinland LGA Products GmbH
399-00-00-DM
Certificate
MDD Annex II (excluding section 4)·SeedIMPULSE SA·ITALCERT SRL·1 Basic UDI-DI
n.0068/QCO-D/249-2020
Certificate
MDD Annex II (excluding section 4)·Saria Mehr Co.Ltd·MTIC InterCert S.r.l.·1 Basic UDI-DI
n.0068/QCO-DM/249-2020
Certificate
MDD Annex II (excluding section 4)·Saria Mehr Co.Ltd·MTIC InterCert S.r.l.·11 Basic UDI-DIs
HX 1804155-1
Certificate
IVDR QMS·Dominion Biologicals Limited·TÜV Rheinland LGA Products GmbH
D1007400034
Certificate
MDD Annex II (excluding section 4)·POLYTECH Health & Aesthetics GmbH·MDC MEDICAL DEVICE CERTIFICATION GMBH·1 Basic UDI-DI
D1007400037
Certificate
MDD Annex II Section 4·POLYTECH Health & Aesthetics GmbH·MDC MEDICAL DEVICE CERTIFICATION GMBH·1 Basic UDI-DI
HX 1037243-1
Certificate
IVDR QMS·Bio-Rad Medical Diagnostics GmbH·TÜV Rheinland LGA Products GmbH
DZ 2024665-1
Certificate
MDR QA·HangZhou Wellfor Healthcare Co.,LTD.·TÜV Rheinland LGA Products GmbH
DZ 2421775-1
Certificate
MDR QA·Hunan Kangfutai Medical Devices Co.,Ltd.·TÜV Rheinland LGA Products GmbH
DZ 2184522-1
Certificate
MDR QA·Jiangsu Jianyou Medical Technology Co., Ltd.·TÜV Rheinland LGA Products GmbH
HX 1804149-1
Certificate
IVDR QMS·Immucor GTI Diagnostics, Inc·TÜV Rheinland LGA Products GmbH
IX 1191616-6
Certificate
IVDR Technical Documentation·IMMUCOR Medizinische Diagnostik GmbH·TÜV Rheinland LGA Products GmbH
IX 1191616-10
Certificate
IVDR Technical Documentation·IMMUCOR Medizinische Diagnostik GmbH·TÜV Rheinland LGA Products GmbH
IX 1191616-14
Certificate
IVDR Technical Documentation·IMMUCOR Medizinische Diagnostik GmbH·TÜV Rheinland LGA Products GmbH