DGX - BEUDAMED

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T

Certificate

MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·8 Basic UDI-DIs

Certificate

MDD Annex II (excluding section 4)·DGH Technology, Inc.·SGS Belgium NV·5 Basic UDI-DIs

Certificate

MDD Annex II (excluding section 4)·Pro-Dex, Inc.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs

Importer

🇩🇰 Denmark

FDA Pre-Market Approval

FDA Class 3 ·IFORIA 5/7 DR-T/VR-T/VR-T DX; INVENTRA 7 DR-T/VR-T/VR-T DX; IPERIA 5/7 DR-T/VR-T/VR-T DX; LUMAX 300/340 DR/DR-T/VR/VR-T

FDA registration

MEDICON HELLAS SA·6 products·🇬🇷 Greece

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS