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