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THD Revolution - HSA Registration DE0501487

Access comprehensive regulatory information for THD Revolution in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501487 and owned by THD S.p.A.. The device was registered on April 09, 2018.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0501487
THD Revolution
HSA Registration Number: DE0501487
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Product Description

THD Revolution is intended to be used for the surgical treatment of haemorrhoidal disease. This treatment is based on the Doppler-guided Transanal Haemorrhoidal Dearterialization technique. The technique consists of locating and ligating the terminal branches of the superior haemorrhoidal artery using the THD Revolution device and the compatible single-use THD kits. THD Revolution and its accessories may exclusively be used by specialist physicians for ligation of the terminal branches of the superior haemorrhoidal artery in hospital facilities (or suitable aseptic outpatient facilities). Furthermore, by using the optic fiber accessory of the THD Revolution, it can be used in modality โ€œLight Sourceโ€, to support the different THD diagnostic devices.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0501487
Registration Date
April 09, 2018
Change Notification Approval Date
March 12, 2025
Retention Due Date
April 08, 2026
Product Owner
Short Name
THD S.p.A.
Address
Via per Carpi, 15/B, 42015 Correggio (RE) โ€“ Italy, ITALY
Registrant
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model Information
Model Name(s)
THD Doppler Probe THD Revolution THD Reusable Needle Holder THD Doppler Probe THD Doppler Probe THD Revolution THD Fiber Optic Cable THD Bent End Tip THD Foot Pedal THD Straight End Tip THD Fiber Optic Cable (Bent End Tip) THD Fiber Optic Cable (Straight End Tip) Power Supply Cable
Model Identifier(s)
700001 700017 750001 800056 800063 800133 880002 880004 880006 880007 880012 880013 cable