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GEM Glubran 2 Surgical Glue and Application Devices - HSA Registration DE0506107

Access comprehensive regulatory information for GEM Glubran 2 Surgical Glue and Application Devices in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506107 and owned by GEM Srl. The device was registered on August 25, 2021.

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 D
DE0506107
GEM Glubran 2 Surgical Glue and Application Devices
HSA Registration Number: DE0506107
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Product Description

GLUBRAN 2 has an adhesive, sealant, haemostatic, sclerosing, embolic and bacteriostatic effect on tissues. It may be applied alone or in association with suturing stitches. Given below are examples of applications in various types of surgery: General surgery - As an adhesive in both traditional and laparoscopic inguinal hernia repair surgery with patches; Treatment of anal and perianal fistulas. Gynaecological surgery - As an adhesive agent in vaginal and perineal plastic surgery. Urological surgery - Treatment of urinary fistulas; As suture in circumcision interventions. Digestive tract endoscopy - Endoscopic treatment of oesophageal and gastric varices. Interventional radiology and vascular neuroradiology - Arterial and venous embolizations. Interventistic and haemodynamic cardiology - To ensure haemostasis after removal of vascular introducers in femoral endovascular procedures.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0506107
Registration Date
August 25, 2021
Change Notification Approval Date
October 25, 2024
Retention Due Date
August 24, 2025
Product Owner
Short Name
GEM Srl
Address
Via dei Campi, 2, 55049 Viareggio LU, ITALY
Registrant
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Importer
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model Information
Model Name(s)
Dispensing Tip 1 ml Luer Lock Syringe Surgical Glue Glubran 2 Surgical Glue Glubran 2 Surgical Glue Glubran 2 Surgical Glue Glubran 2 Surgical Glue Glubran 2 Surgical Glue Glubran 2 Drop Control Device Laparoscopic Catheter Rigid Laparoscopic Catheter Spray Device Rigid Spray Device Short Spray Device Short Small Spray Device Small Spray Device Glubran 2 Seal Device Glubran 2 Seal Device Glutack 25 Glutack 40 Glutack 50
Model Identifier(s)
G-DT G-LLS G-NB-2 G-NB2-35 G-NB2-50 G-NB2-60 G-NB2-75 G-NB2S-25 G2-DCD-210-8T G2-LPC G2-LPC-RIG G2-NBT G2-NBT-RIG G2-NBT-SHORT G2-NBT-SM-SHORT G2-NBT-SMALL G2-SL 5/6 G2-SL 7/8 GB-DS 25 GB-DS 40 GB-DS 50