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Sources: EU EUDAMED, US FDA
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Country: France
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FCI SAS
FDA registration
FCI SAS·30 products·🇫🇷 France
RISKONTROL DCI
Device
EU MDR
·
Eu Md Class 1
·ACTEON MANUFACTURING·On the market·21 countries
FCI FRANCE CHIRURGIE INSTRUMENTATION
FDA registration
FCI FRANCE CHIRURGIE INSTRUMENTATION·31 products·🇫🇷 France
DENTAL COMPONENTS EUROPE
Authorized representative
🇫🇷 France·1 Manufacturer·2 Devices
The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).
FDA Enforcement
Class II
·Terminated·Peters Surgical·October 1, 2014
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).
FDA Enforcement
Class II
·Terminated·Peters Surgical·October 1, 2014
France Chirurgie Instrumentation SAS (FCI S.A.S.)
System producer
🇫🇷 France
ACTEON MANUFACTURING
Manufacturer
🇫🇷 France·12 Basic UDI-DIs·77 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS
MED.e.Com
Manufacturer
🇫🇷 France·4 Basic UDI-DIs·7 Devices·SGS Belgium NV
DIAGAST
Manufacturer
🇫🇷 France·9 Basic UDI-DIs·15 Devices·GMED SAS
TODA PHARMA
Manufacturer
🇫🇷 France·26 Basic UDI-DIs·27 Devices·BSI Group The Netherlands B.V.
3S ORTHO
Manufacturer
🇫🇷 France·14 Basic UDI-DIs·14 Devices·Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., Kiwa Belgelendirme Hizmetleri A.Ş., and Kiwa Belgelendirme Hizmetleri A.Ş.
ALN
Manufacturer
🇫🇷 France·19 Basic UDI-DIs·19 Devices·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH
EUROSILICONE SAS
Manufacturer
🇫🇷 France·490 Basic UDI-DIs·490 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.
Rocamed France
Manufacturer
🇫🇷 France·25 Basic UDI-DIs·25 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS
DIXI Medical
Manufacturer
🇫🇷 France·18 Basic UDI-DIs·24 Devices·GMED SAS, GMED SAS, and GMED SAS
Ortho Cape
Manufacturer
🇫🇷 France·82 Basic UDI-DIs·82 Devices·HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), and HTCert (Health Technology Certification Ltd)
LIFEAZ SAS
Manufacturer
🇫🇷 France·11 Basic UDI-DIs·11 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
SCHILLER MEDICAL
Manufacturer
🇫🇷 France·10 Basic UDI-DIs·10 Devices·GMED SAS, GMED SAS, and GMED SAS
EUROSPINE SARL
Manufacturer
🇫🇷 France·614 Basic UDI-DIs·614 Devices·SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV