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

MSP Medical Spare Parts

System producer

🇳🇱 Netherlands

Protective Barrier Enclosure

FDA classification

FDA Not Classified ·Protective Barrier Enclosure

Frames CP mix fullrim

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Sunoptic International Ltd·1 device

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification

FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

GCP-Service International Ltd. & Co. KG

Authorized representative

🇩🇪 Germany

Frames CP mix fullrim sun

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Sunoptic International Ltd·1 device

IVDD 21 061 0128

Certificate

IVDD Annex IV Section 4·MP Biomedicals Asia Pacific Pte Ltd·bqs. s.r.o.·2 Basic UDI-DIs

IVDD 21 062 0130

Certificate

IVDD Annex IV Section 4·MP Biomedicals Asia Pacific Pte Ltd·bqs. s.r.o.·2 Basic UDI-DIs

IVDD 21 060 0126

Certificate

IVDD Annex IV Section 4·MP Biomedicals Asia Pacific Pte Ltd·bqs. s.r.o.·2 Basic UDI-DIs

V7 068207 0046

Certificate

IVDD Annex IV Section 4·MP Biomedicals Asia Pacific Pte Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

BioButton (In Bulk Packaging)

FDA UDI

BIOINTELLISENSE, INC.·00850005949282·The BioButton™ is a remote monitoring wearable ...

Pat Coakley Medical Ltd.

Importer

🇮🇪 Ireland·6 Manufacturers

BioButton Rechargeable Adhesives (ADD-HT)

FDA UDI

BIOINTELLISENSE, INC.·00850005949244·Adhesive accessory packs for wearable devices -...

MedEnvoy Global BV

Authorized representative

🇳🇱 Netherlands·143 Manufacturers·2306 Devices

MDSS GmbH

Authorized representative

🇩🇪 Germany·388 Manufacturers·16562 Devices

Advena Limited

Authorized representative

🇲🇹 Malta·467 Manufacturers·13717 Devices

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices