CE mark approval articles & resources on Made-in-China.com

Nevro's Stock up More Than 20% From Where It Was Late Last Week

Jan 28, 2015

The Nevro Senza, as shown in a video on the company's website. Nevro’s stock is now up more than 20% from where it was late last week, after the Menlo Park, CA–based company said that the FDA has deemed the PMA for its spinal ...

Tags: spinal pain-killing device, Health

CareDx Intends to Make an IPO of Common Stock with The Intent of Realizing $50 Million.

Jun 13, 2014

CareDx. which two weeks ago entered into an agreement to acquire ImmuMetrix Inc., has announced that it intends to make an initial public offering (IPO) of common stock with the intent of realizing $50 million. Brisbane, CA–based ...

Tags: Health, Medicine

CQC Certification Business Was Introduced

Apr 11, 2014

A, CCC Certification CNCA authorized by the state under the state compulsory product certification (CCC) work. Second, CQC logo certification CQC facilities in order to increase the way of signs show that the products meet ...

Tags: CQC Certification, certification, CQC

Tryton Medical Obtains CE Mark for The Treatment of Left Main Coronary Artery Disease

Feb 19, 2014

Tryton Medical, a developer of stents designed to treat bifurcation lesions, has received CE Mark for the treatment of left main coronary artery disease. With this approval, Tryton Medical becomes the first company to earn a CE Mark for ...

Tags: Tryton Medical, CE-Mark

Sapheon Announces Health Canada Approval for Its Venaseal Sapheon Closure System

Feb 7, 2014

Sapheon has announced the Health Canada approval for its VenaSeal sapheon closure system, designed to treat venous reflux disease (varicose veins). VenaSeal features a specially formulated medical adhesive that closes the saphenous vein. ...

Tags: FDA, VeClose, IDE, VenaSeal

Claret Medical Gets CE Mark Approval for Sentinel Cerebral Protection System

Feb 7, 2014

US-based Claret Medical has obtained CE Mark approval for Sentinel Cerebral Protection System, the next generation product in its embolic protection portfolio. Claret Medical's Sentinel cerebral protection system (CPS) is designed for ...

Tags: CPS, TAVR, filter system, exemption

Medtronic's Corevalve System for Severe Aortic Stenosis Was Approved by FDA

Jan 21, 2014

Medtronic, a medical device company, has obtained the US Food and Drug Administration (FDA) approval for its CoreValve self-expanding transcatheter system. The device is designed for severe aortic stenosis patients who are too ill or ...

Tags: medical device, Medtronic

Distribution Agreement Was Signed by Integrity Applications, Ultramedix

Jan 15, 2014

Integrity Applications and Ultramedix Australasia have signed an agreement for the distribution of Integrity Applications’ GlucoTrack non-invasive blood glucose measurement device in Australia and New Zealand. Subject to the ...

Tags: Monitoring Device, Integrity Applications

Zyomyx's MyT4 Point-of-Care CD4 Diagnostic Test Has Received The CE Certificate

Jan 10, 2014

Mylan, Inc. (Nasdaq: MYL) today announced that Zyomyx's MyT4™ point-of-care CD4 diagnostic test has received the CE Certificate of Conformity in the European Union, an important step toward launching this innovative test and expanding ...

Tags: Mylan, Zyomyx's MyT4™point-of-care CD4, diagnostic test, HIV

Kalila Medical Has Received CE Mark Approval for Its Vado Steerable Introducer Sheath

Jan 9, 2014

Kalila Medical, a privately held medical device company focused on the development of next-generation steerable catheter technologies, today announced it has received CE mark approval for its Vado™ Steerable Introducer Sheath for ...

Tags: Kalila Medical, CE mark approval, Vado™Steerable Introducer Sheath

Baxter Today Announced Completion of CE Marking in Europe for The VIVIA HD System

Dec 23, 2013

Baxter International Inc. (NYSE:BAX) today announced completion of CE marking in Europe for the VIVIA hemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home HD therapy, known as High ...

Tags: CE, health, medicine

FDA 510(K) Approval for Bone Anchored Sound Processors Is Obtained by Oticon Oticon Medica

Dec 20, 2013

Oticon Medical, a manufacturer of bone anchored hearing systems, has obtained 510(k) approval the US Food and Drug Administration (FDA) to market its Ponto Plus bone anchored sound processors in regular version (down to a hearing loss of ...

Tags: Oticon Medical, Ponto Plus Bone

Randomization of First Patients in Symplicity HTN-4 Trial is declared by Medtronic

Dec 19, 2013

US-based medical technology company Medtronic has announced the randomization of the first patients in the SYMPLICITY HTN-4 clinical trial at Medical University of South Carolina, Piedmont Heart Institute and Duke University Medical Center. ...

Tags: Health, Medicine

CE Mark Approval for X4 Quadripolar CRT-D Systems Is Obtained by Boston Scientific

Dec 19, 2013

Boston Scientific has obtained CE Mark approval for its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds), a suite of ACUITY X4 quadripolar LV ...

Tags: CRT-D Systems, CE Mark

Approval for 25mm Portico Transcatheter Aortic Heart Valve Is Obtained by St. Jude Medical

Dec 16, 2013

St. Jude Medical, a medical device company, has obtained CE Mark approval in Europe for its 25mm Portico transcatheter aortic heart valve implantation system. The Portico valve system offers a minimally invasive treatment option for ...

Tags: St.Jude Medical, Aortic Heart Valve

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