OsOpia Synthetic Bone Void Filler

FDA 510(k)

FDA Class 2 ·Dental

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM

MCC MEDICAL DISPOSABLES,SL

Importer

🇪🇸 Spain

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

BioButton At-Home Kit with Power Adaptor

FDA UDI

BIOINTELLISENSE, INC.·00850005949312·BioButton At-Home Kit with Power Adaptor

APLICARE

FDA UDI

MEDLINE INDUSTRIES, INC.·00618407611066·SWABSTCK, BENZOIN TINCTURE, 1/PK, STRL

BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton

FDA UDI

BIOINTELLISENSE, INC.·00850005949343·BioButton At-Home Kit with Power Adaptor, Adhes...

BioButton At-Home Kit

FDA UDI

BIOINTELLISENSE, INC.·00850005949381·BioButton At-Home Kit

BioButton v3 (BBN-r, different batch, Individual Pack)

FDA UDI

BIOINTELLISENSE, INC.·00850005949220·Note: 00850005949220 (Model# BIOST06040) is equ...

BioButton At-Home Kit with Power Adaptor and Adhesives

FDA UDI

BIOINTELLISENSE, INC.·00850005949404·BioButton At-Home Kit with Power Adaptor and Ad...

Medline

FDA UDI

MEDLINE INDUSTRIES, INC.·10884389123430·ADAPTER,CATHETER/SYRINGE/LUER,STERILE

BioButton At-Home Kit with Adhesives and BioButton

FDA UDI

BIOINTELLISENSE, INC.·00850005949367·BioButton At-Home Kit with Adhesives and BioButton

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

MBC Medical Bio Care GmbH

Importer

🇩🇪 Germany

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