COMING SOON
Synergo® SB-TS 101.3
Disposable sets: LI932B, LI932B-S, CDS932B
Basic UDI-DI:
7290010121SYN101VJ (SB-TS 101.3 & LI932B/LI932B-S) - Device classification IIb
7290010121CDS932BPM (CDS932B) - classification IIa
Intended Use
The Synergo System is intended for the treatment of intermediate risk, high-risk and very-high risk adult patients
with non-muscle invasive bladder cancer (NMIBC) by providing localized radiofrequency (RF) induced
bladder wall hyperthermia in combination with concurrent intravesical administration of mitomycin C (MMC)
or epirubicin. The device is intended for adjuvant (prophylactic) and neoadjuvant (ablative) treatment and intended
for use by trained healthcare professionals in hospital, clinic, or outpatient healthcare settings.
Intended Users
The Synergo® RITE treatment should be performed by medical personnel (e.g. physician, nurse, medical
technician, etc.) who have undergone training by Medical Enterprises Group in the use of the Synergo® equipment, including practical hands-on training.
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If you experience a problem with one of our medical devices or wish to report a product complaint, please contact our team as soon as possible. To help us investigate your report promptly, include the clinic/hospital name, contact details, product name and model or catalog number, LOT or serial number, a description of the issue, the date the event occurred, and your contact information. If the event involved a patient or user, please include a brief description of the outcome, without providing personally identifiable information.
Email: info[at]synergo-medical.com or contact us by phone: +31 20 6423719 or +972 3 9244830
Our team will acknowledge your report and may contact you for additional information to support our investigation.
By contacting our team, you acknowledge that your email may be retained for quality assurance purposes. We may collect and process your personal information to respond to your inquiry, comply with legal obligations (including product safety requirements), investigate reported issues, and improve our products. Your information may be shared with regulatory authorities and affiliated entities, including those in the United States, where different data protection standards may apply.