Singapore HSA registration DE0019011
Ethicon Prolene Soft Polypropylene Mesh
Singapore·CLASS C·Ethicon LLC·Registered February 27, 2017Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Obstetrics & Gynaecology
Registration information
- Registration Number
- DE0019011
- Registration Date
- February 27, 2017
- Change Notification Approval Date
- November 06, 2023
- Retention Due Date
- February 26, 2026
Product description
PROLENE Soft Mesh is indicated for the repair of abdominal wall hernias that require the addition of a reinforcing material to obtain the desired surgical result.
Product Owner
- Name
- Ethicon LLC
- Short Name
- Ethicon LLC
- Address
- Highway 183 Km 8.3, San Lorenzo, 00754, Puerto Rico, UNITED STATES
Registrant
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
- Model Name(s)
- PROLENE* Polypropylene Soft Mesh PROLENE* Polypropylene Soft Mesh PROLENE* Polypropylene Soft Mesh PROLENE* Polypropylene Soft Mesh PROLENE* Polypropylene Soft Mesh PROLENE* Polypropylene Soft Mesh
- Model Identifier(s)
- SPMH SPMII SPMLI SPMS SPMXS SPMXXL
About this record
Access comprehensive regulatory information for Ethicon Prolene Soft Polypropylene Mesh in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019011 and owned by Ethicon LLC. The device was registered on February 27, 2017.
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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