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Ethicon Prolene Soft Polypropylene Mesh - HSA Registration DE0019011

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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CLASS C
DE0019011
Ethicon Prolene Soft Polypropylene Mesh
HSA Registration Number: DE0019011
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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.

Device 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 Owner
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