Medical device manufacturer Life Care Medical Devices (LCMD) has obtained CE mark approval for its Keyhole Cup Laparoscopic Access Device. The device, unlike the previous procedures that involved inherent risk of injury to organs lying ...
Tags: Medical device, Medical, CE Mark
Theradiag has received a CE mark approval for its anti cyclic citrullinated peptide (anti-CCP) in vitro diagnostic (IVD) kit in rheumatoid arthritis. The test further expands the Fidis portfolio of diagnostic tests for auto-immunes ...
Ventripoint Diagnostics has obtained CE mark certification from European notified body Intertek Semko for its NRV application for the VMS-2DE heart analysis system. The NRV database can be used in conjunction with right heart analysis ...
Tags: Ventripoint, CE Mark, NRV Application
St. Jude Medical has obtained CE mark for its deep brain stimulation (DBS) systems, designed for the treatment of primary and secondary dystonia. The Brio, Libra and LibraXP DBS devices, which are placed using two thin leads with small ...
Tags: St.Jude Medical, CE mark
The European Union (EU) has granted CE mark certification to Medtronic's Sentrant Introducer Sheath for the endovascular repair of aortic aneurysms. Designed for use with the company's Endurant II AAA and Valiant Captivia Stent Graft ...
Tags: aortic aneurysms, Medtronic, Sentrant Introducer Sheath
NuvoLase has obtained CE mark approval for its PinPointe FootLaser device, designed for treating nail fungus infection. The approval will allow the company to market the device and continue to serve its customers throughout the European ...
Apollo Endosurgery has obtained CE mark approval for its OverStitch endoscopic suturing system, designed for offering less invasive options during various endoscopic surgical procedures. With the approval, the company is planning to ...
Tags: EU, Endoscopic Suturing System, Medicine
Aptus Endosystems has received CE mark approval from the European Union for its thoracic-length Heli-FX system for thoracic aortic aneurysms (TAA) treatment. Featuring a longer delivery device with additional tip configurations, the ...
Tags: Heli-FX System, Medicine, Medical Device
GS mark is accepted by the majority of customers the security of the European flag. GS certified product sales are usually higher priced and more popular. European CE requirements, 1997.1.1. From control "Low Voltage Directive ...
Tags: GS, Certification
LED lighting products are the EU Safety Directive – Low Voltage Directive (LVD Directive) jurisdiction, on entering the EU market, identifies the CE mark, you must consider the relevant standards under the LVD directive. ...
US-based diagnostic testing solutions provider Quidel has gained CE Mark for its Quidel Molecular Direct HSV 1+2/VZV assay for the differentiation and detection of herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) in ...
Tags: CE Mark, Molecular Direct, diagnostic testing solutions
The European Union (EU) has granted CE mark approval to iTraumaCare's iTClamp Hemorrhage Control System, designed for controlling critical bleeding in seconds. The device seals the edges of a wound to create a temporary pool of blood ...
Tags: iTraumaCare, medical professionals, medical
SOOFT italia, a OOgroup company, has obtained CE mark approval for its iontophoresis device for corneal cross-linking. The device, which includes Ricrolin+ and a new Power Generator I-ON CXL, allows the riboflavin to penetrate in the ...
Tags: SOOFT italia, CE mark, corneal cross linking
The British Standards Institution (BSI) has granted ISO 13485:2003 certification to Cardium Therapeutics' Excellagen advanced wound care gel product. Excellagen, which is designed for application at only one-week intervals, is a fibrillar ...
MakieLab also picks up an Entertainment and Gaming award. Over 100,000 digital Makie doll characters have been created to date. The news comes as creator of the 3D printed dolls, MakieLab, is honoured at the SXSW 5th Annual Accelerator ...
Tags: makielab, Digital Makie, Gaming