3,888 results · 38ms · Sources: EU EUDAMED, US FDA

COMPUTERISED OPTICAL BIOMETERS

Device
EU MDR · Eu Md Class 2b ·Haag-Streit AG·On the market·32 countries

COMPUTERISED OPTICAL BIOMETERS

Device
EU MDR · Eu Md Class 2a ·Haag-Streit AG·On the market·32 countries

Slit Lamp BQ 900

Device
EU MDR · Eu Md Class 1 ·Haag-Streit AG·On the market·32 countries

Phoropter Refractor 900

Device
EU MDR · Eu Md Class 1 ·Haag-Streit AG·On the market

Contact Lens 902 S

Device
EU MDR · Eu Md Class 1 ·Haag-Streit AG·On the market·32 countries

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

Radioimmunoassay, Estriol

FDA classification
FDA Class 1 ·Radioimmunoassay, Estriol

Breast Milk, Rhodamine, Antigen, Antiserum, Control

FDA classification
FDA Class 1 ·Breast Milk, Rhodamine, Antigen, Antiserum, Control

Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

FDA classification
FDA Class 1 ·Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

Immunocytochemistry Assay, P16/Ki-67

FDA classification
FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

Triolab AS

Importer
🇩🇰 Denmark·11 Manufacturers

Endoscopic Guidewire, Gastroenterology-Urology

FDA classification
FDA Class 2 ·Endoscopic Guidewire, Gastroenterology-Urology

Gastrointestinal Motility System, Capsule

FDA classification
FDA Class 2 ·Gastrointestinal Motility System, Capsule

Endoscopic Injection Needle, Gastroenterology-Urology

FDA classification
FDA Class 2 ·Endoscopic Injection Needle, Gastroenterology-Urology

Incontinence pantyliner

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Intigena (Schweiz) AG·1 device

Incontinence Pants

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Intigena (Schweiz) AG·4 devices

Incontinence Pads

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Intigena (Schweiz) AG·6 devices

ΚΛΕΟΜΕΝΗΣ ΜΑΝΕΤΑΣ - ΕΥΑΓΓΕΛΟΣ ΡΟΔΑΜΙΤΗΣ KAI ΣΙΑ Ο.Ε. (ENDOCARE MEDICALS)

Importer

Hemostatic Metal Clip For The Gi Tract

FDA classification
FDA Class 2 ·Hemostatic Metal Clip For The Gi Tract