Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE PATIENT DISINFECTION UNIT

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 - CLEAR

H.D. HEALTH DEFENCE S.R.L.

Importer

🇮🇹 Italy

Rubicon Technical Limited

Authorized representative

🇳🇱 Netherlands·3 Manufacturers

PUNCTUA CRT-D

FDA registration

Boston Scientific Corporation·5 products·🇺🇸 United States

PUNCTUA CRT-D

FDA registration

Boston Scientific Corporation·5 products·🇺🇸 United States

PUNCTUA CRT-D

FDA registration

Boston Scientific Limited·5 products·🇮🇪 Ireland

Cd-R, Cd-Rw Recorder

FDA classification

FDA Not Classified ·Cd-R, Cd-Rw Recorder

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

FDA registration

CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI·6 products·🇹🇷 Türkiye

Amplia MRI CRT-D SureScan

FDA registration

Medtronic Europe Sarl·6 products·🇨🇭 Switzerland

Amplia MRI CRT-D SureScan

FDA registration

MEDTRONIC SOFAMOR DANEK USA, INC.·6 products·🇺🇸 United States

Amplia MRI CRT-D SureScan

FDA registration

Medtronic Distribution Center·6 products·🇺🇸 United States

Amplia MRI CRT-D SureScan

FDA registration

MEDTRONIC, INC.·6 products·🇺🇸 United States

Amplia MRI CRT-D SureScan

FDA registration

Medtronic Engineering and Innovation Center (MEIC)·6 products·🇮🇳 India

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·22 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI