MANC-OUT-NI

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ACIME FRAME·1 device

Oragene Dx

FDA UDI

DNA Genotek Inc·00627595000248·DNA Specimen Collection, Saliva

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBS TEST SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS HBSAG TEST SYSTEM

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T-SPOT TB TEST

6895-1364 - ADANTE FRICTION PAD

FDA registration

MIZUHO ORTHOPEDIC SYSTEMS, INC.·1 product·🇺🇸 United States

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SURESTAT ARTERIAL CLOSURE SYSTEM

Van der Logt Group B.V.

Importer

🇳🇱 Netherlands·7 Manufacturers

OMT GmbH & Co. KG

Importer

🇩🇪 Germany

System, Imaging, Optical Coherence Tomography (Oct)

FDA classification

FDA Class 2 ·System, Imaging, Optical Coherence Tomography (Oct)

TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK

FDA 510(k)

FDA Class 2 ·General Hospital

THE IVY POLE-INTRAVENOUS BOT TREES #1121K & 1221K

FDA 510(k)

FDA Class 1 ·General Hospital

Test, Nr2 Antibody

FDA classification

FDA Not Classified ·Test, Nr2 Antibody

Radioimmunoassay, Cyclic Gmp

FDA classification

FDA Class 2 ·Radioimmunoassay, Cyclic Gmp

Controller, Temperature, Radiographic

FDA classification

FDA Class 2 ·Controller, Temperature, Radiographic

Optical Diagnostic Device For Melanoma Detection

FDA classification

FDA Class 3 ·Optical Diagnostic Device For Melanoma Detection

G1 057451 0044

Certificate

MDD Annex II (excluding section 4)·Vogt Medical Vertrieb GmbH·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

G7 057451 0041

Certificate

MDD Annex II Section 4·Vogt Medical Vertrieb GmbH·TÜV SÜD Product Service GmbH·34 Basic UDI-DIs

G1 057451 0044

Certificate

MDD Annex II (excluding section 4)·Vogt Medical Vertrieb GmbH·TÜV SÜD Product Service GmbH·36 Basic UDI-DIs

G7 057451 0041

Certificate

MDD Annex II Section 4·Vogt Medical Vertrieb GmbH·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs