32 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: France
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UNIC®
Device
EU MDR
·
Eu Md Class 3
·EVOLUTIS·On the market·12 countries
Pied à sérum
Device
EU MDR
·
Eu Md Class 1
·COMED SAS·On the market·1 country
Soluscope SAS
Manufacturer
🇫🇷 France·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Soluscope PAA
Device
EU MDD
·
Eu Md Class 2b
·Soluscope SAS·On the market·7 countries
ANNIE BAUER CONFORT
Authorized representative
🇫🇷 France·1 Manufacturer·599 Devices
Synergie Ingénierie Médicale
Importer
🇫🇷 France·1 Manufacturer
Symbios France SAS
Importer
🇫🇷 France·1 Manufacturer
Symbios France SAS
Authorized representative
🇫🇷 France·1 Manufacturer
Synergie Ingénierie Médicale
Authorized representative
🇫🇷 France·1 Manufacturer
EMS FRANCE SARL
Authorized representative
🇫🇷 France·1 Manufacturer
Haemonetics France SARL
Importer
🇫🇷 France·2 Manufacturers
SL Medirep SAS
Authorized representative
🇫🇷 France·2 Manufacturers·33 Devices
SAS Isocèle Conseil
Authorized representative
🇫🇷 France·2 Manufacturers·119 Devices
ANNIE BAUER CONFORT
Importer
🇫🇷 France·2 Manufacturers
12974
Certificate
MDD Annex II (excluding section 4)·S.A. GERMITEC·GMED SAS·1 Basic UDI-DI
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
FDA Enforcement
Class III
·Terminated·Technidata S.A.·July 24, 2013
TD-Synergy. Laboratory Information System.
FDA Enforcement
Class II
·Terminated·Technidata S.A.·May 29, 2013
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
FDA Enforcement
Class II
·Terminated·MEDICAMAT S.A.·March 12, 2014