Singapore HSA registration DE0503366
THD Sphinkeeper
Singapore·CLASS C·THD S.p.A.·Registered July 16, 2019Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0503366
- 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 SphinKeeper 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
- 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 Sphinkeeper Delivery System THD Sphinkeeper Self Expandable Implant THD Sphinkeeper - 10x Self Expandable Implant
- Model Identifier(s)
- 820009 820010 820015
About this record
Access comprehensive regulatory information for THD Sphinkeeper in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503366 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.
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