2,213 results · 44ms · Sources: EU EUDAMED, US FDA

Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Randox Laboratories Limited·1 device

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval
FDA Class 3 ·MEDSTONE STS LITHOTRIPTER

Anti-Coa, for card method Coombs-reactive, polyclonal, human IgG

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·1 device

Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

FDA classification
FDA Class 2 ·Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

Board, Cardiopulmonary

FDA classification
FDA Class 1 ·Board, Cardiopulmonary

Joh. Th. Schulte bv

Authorized representative
🇳🇱 Netherlands

Sterile Vacuum Vials

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Huayi Isotopes Co. (a division of Jiangsu Huayi Technology Co., Ltd.)·2 devices

Mills Enterprises LTD Oy

Importer
🇫🇮 Finland·6 Manufacturers

JFA Medical Wound Closure Strips 3mmx75mm, 5 strips per pouch - single pouch

Basic UDI-DI
EU MDD · Eu Md Class 1 ·Suzhou Sunmed Co.,Ltd.·1 device

Remedee wristband OA

Basic UDI-DI
EU MDR · Eu Md Class 2a ·Remedee Labs SA·2 devices

TNP/MDD/0253/4835/2019

Certificate
MDD Annex II (excluding section 4)·JO-VITAL Jowita Wietecha·TUV NORD Polska Sp. z o.o·6 Basic UDI-DIs

Fall Prevention Alarm/Sensor Attached Only

FDA classification
FDA Class 1 ·Fall Prevention Alarm/Sensor Attached Only

Bracket, Ceramic, Orthodontic

FDA classification
FDA Class 2 ·Bracket, Ceramic, Orthodontic

Patient Specific Manual Navigation System

FDA classification
FDA Class 2 ·Patient Specific Manual Navigation System

Scissors, Wire Cutting, Ent, Non-Sterile

FDA classification
FDA Class 1 ·Scissors, Wire Cutting, Ent, Non-Sterile

Patient Specific Manual Orthopedic Stereotaxic System

FDA classification
FDA Class 2 ·Patient Specific Manual Orthopedic Stereotaxic System

Ear, Nose, And Throat Stereotaxic Instrument

FDA classification
FDA Class 2 ·Ear, Nose, And Throat Stereotaxic Instrument

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

FDA classification
FDA Class 2 ·Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

FDA classification
FDA Class 2 ·Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

FDA classification
FDA Class 2 ·Endoscopic Video Imaging System/Component, Gastroenterology-Urology