Pure Global

Davol SORBAFIX™ Absorbable Fixation System - HSA Registration DE0010114

Access comprehensive regulatory information for Davol SORBAFIX™ Absorbable Fixation System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0010114 and owned by Davol Inc. The device was registered on September 04, 2012.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS D
DE0010114
Davol SORBAFIX™ Absorbable Fixation System
HSA Registration Number: DE0010114
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The SorbaFix™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during laparoscopic surgical procedures, such as hernia repair.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0010114
Registration Date
September 04, 2012
Change Notification Approval Date
December 16, 2024
Retention Due Date
September 03, 2025
Product Owner
Short Name
Davol
Address
100 Crossing Boulevard, Warwick, RI 02886, UNITED STATES
Registrant
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model Information
Model Name(s)
SORBAFIX™ Laparoscopic Fixation Device SORBAFIX™ Laparoscopic Fixation Device
Model Identifier(s)
0113115 0113116