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Werfen receives CE mark for Aptiva® antiphospholipid syndrome reagents

Werfen, announced that it has received the CE ( Conformité EuropéenneAptiva  Immunoglobulin G ( IgG ) and Immunoglobulin M ( IgM ) Reagents for Antiphospholipid Syndrome ( APS ). under the European Union ( EUVitro Diagnostic Medical Devices Regulation ( IVDR ) . Aptiva...

Tivic Announces Successful Recertification of ISO 13485 Quality Management System and the European Medical Device CE-Mark

Tivic Health Systems, Inc, a commercial-phase health technology company that develops and commercializes bioelectronic medicine,  announced it has received recertification of ISO 13485, the...

Bioretec Updates Its Estimate of the Timing for Approval of the CE Mark for the Remeos Trauma Screw

Bioretec Ltd, a pioneer in biodegradable orthopedic implants, expects the European marketing authorization for the RemeOs trauma screw to be delayed from the original...

Roche launches its next-generation SARS-CoV-2 Rapid Antibody Test

Roche announced the launch of the SARS-CoV-2 Rapid Antibody Test 2.0 in markets accepting the CE Mark. The test is the next generation of...

Galaxy Medical Receives CE Mark for CENTAURI Pulsed Electric Field System

Galaxy Medical announced that it received the CE Mark for its CENTAURI Pulsed Electric Field (PEF) System and launched its commercial program. The approval...
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