Cb Amateur Radio

FDA classification

FDA Not Classified ·Cb Amateur Radio

1434-MDD-070/2021

Certificate

MDD Annex II (excluding section 4)·MEDI J Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

J.B. Implants Services bv

Importer

🇳🇱 Netherlands

301081783

Certificate

MDD Annex V·President Dental GmbH·ENTE CERTIFICAZIONE MACCHINE SRL·14 Basic UDI-DIs

5-926+200-2105

Certificate

MDD Annex II (excluding section 4)·FIXIER SA DE CV·NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)·1 Basic UDI-DI

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UCB Pharma S.A.

Authorized representative

🇧🇪 Belgium·1 Manufacturer

DZ 2048293-1

Certificate

MDR QA·Jiangxi 3L Medical Products Group Co., Ltd.·TÜV Rheinland LGA Products GmbH

MDD-193

Certificate

MDD Annex V·Biolux Technology GmbH·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ·2 Basic UDI-DIs

193

Certificate

MDD Annex V·Biolux Technology GmbH·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ·1 Basic UDI-DI

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HD 60147227 0001

Certificate

MDD Annex II Section 4·Shenzhen JCR Medical Technology Limited Company·TÜV Rheinland LGA Products GmbH·5 Basic UDI-DIs

Chromatographic Separation/Radioimmunoassay, Aldosterone

FDA classification

FDA Class 2 ·Chromatographic Separation/Radioimmunoassay, Aldosterone

Fab, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fab, Fitc, Antigen, Antiserum, Control

PMS2 (MRQ-28) Mouse Monoclonal Antibody

FDA registration

CELL MARQUE CORP.·1 product·🇺🇸 United States

Detection Systems

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·WellMed BV·1 device

CB Healthcare Consulting GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

SIA Scanmed

Importer

🇱🇻 Latvia·4 Manufacturers

Advena Services Limited

Importer

🇲🇹 Malta·40 Manufacturers

Advena Limited

Authorized representative

🇲🇹 Malta·467 Manufacturers·13717 Devices