Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

FDA 510(k)

FDA Class 2 ·Cardiovascular

2195-MED-2012004

Certificate

MDD Annex II (excluding section 4)·REV-MED Inc.·Szutest Uygunluk Değerlendirme A.Ş.·1 Basic UDI-DI

G1 095551 0002

Certificate

MDD Annex II (excluding section 4)·REV-MED Inc.·TÜV SÜD Product Service GmbH·5 Basic UDI-DIs

Japanese Encephalitis Virus (JEV) Real Time RT-PCR Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

Rév Group s.r.o.

Importer

🇨🇿 Czechia·1 Manufacturer

AB-LEV, d.o.o.

Importer

🇸🇮 Slovenia

DEFIT Regular Silicone Shunt Ventriculoperitoneal Catheter KIT Antisiphon Dev/HIGH/reinforcedbase)

Basic UDI-DI

EU MDD · Eu Md Class 3 ·DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ·1 device

Hepatitis E virus(HEV) IgG Antibody Detection Kit (Magnetic Particle CLIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Tianjin Bioscience Diagnostic Technology Co.,Ltd.·1 device

Rév Gas Industries Ltd.

Importer

🇭🇺 Hungary·1 Manufacturer

Over Rev Unipessoal Lda

Importer

🇵🇹 Portugal

Eating Disorder Conditioning Tool

FDA classification

FDA Class 2 ·Eating Disorder Conditioning Tool

Mycophenolic Acid Test System

FDA classification

FDA Class 2 ·Mycophenolic Acid Test System

Adjunctive Predictive Cardiovascular Indicator

FDA classification

FDA Class 2 ·Adjunctive Predictive Cardiovascular Indicator

Medium-Term Adjunctive Predictive Cardiovascular Indicator

FDA classification

FDA Class 2 ·Medium-Term Adjunctive Predictive Cardiovascular Indicator

I.S. Med Dev Compliance Ltd

Authorized representative

🇨🇾 Cyprus·1 Manufacturer·25 Devices

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

FDA classification

FDA Class 1 ·Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

FIRST AID SHOP OE

Importer

Japanese Encephalitis Virus/Tick-Borne Encephalitis Virus/West Nile Virus/Dengue Virus (JEV/TBEV/WNV/DFV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Japanese Encephalitis Virus/Tick-Borne Encephalitis Virus/West Nile Virus/Dengue Virus (JEV/TBEV/WNV/DFV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

PAPPAS N. & SIA OE

Importer