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Singapore HSA registration DE0503367

THD Gatekeeper

Singapore flagSingapore·CLASS C·THD S.p.A.·Registered July 16, 2019
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0503367
Registration Date
July 16, 2019
Change Notification Approval Date
March 12, 2025
Retention Due Date
July 15, 2025
Product description
The prosthesis contained within the THD GateKeeper Self Expandable Implant is intended to be implanted in the intersphincteric groove of the anal canal for the treatment of fecal incontinence, in patients for whom other available treatments have failed or deemed unsuitable. The prosthesis is implanted by using their corresponding Delivery System.
Product Owner
Name
THD S.p.A.
Short Name
THD S.p.A.
Address
Via per Carpi, 15/B, 42015 Correggio (RE) – Italy, ITALY
Registrant
Name
EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Name
QST TECHNOLOGIES PTE. LTD.
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model information
Model Name(s)
THD Gatekeeper Delivery System THD Gatekeeper Self Expandable Implant THD Gatekeeper - 4x Self Expandable Implant THD Gatekeeper - 6x Self Expandable Implant
Model Identifier(s)
820003 820004 820013 820014
About this record

Access comprehensive regulatory information for THD Gatekeeper in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503367 and owned by THD S.p.A.. The device was registered on July 16, 2019.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C