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Ferrosan SPONGOSTAN* - HSA Registration DE0005390

Access comprehensive regulatory information for Ferrosan SPONGOSTAN* in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0005390 and owned by Ferrosan Medical Devices A/S. The device was registered on August 24, 2010.

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
DE0005390
Ferrosan SPONGOSTAN*
HSA Registration Number: DE0005390
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Product Description

SPONGOSTAN* Powder, saturated with sterile sodium chloride solution, or SPONGOSTAN* sponge, used dry or saturated with sterile sodium chloride solution, is indicated for surgical procedures (except urologic and ophthalmic) for haemostasis, when control of capillary bleeding, oozing bleeding, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. Although not necessary, SPONGOSTAN* can be used either with or without thrombin to achieve haemostasis.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDD00110
HS Code
30061090
Registration Information
Registration Number
DE0005390
Registration Date
August 24, 2010
Change Notification Approval Date
October 07, 2024
Retention Due Date
August 23, 2025
Product Owner
Short Name
Ferrosan Medical Devices A/S
Address
Sydmarken 5, 2860 Soeborg, DENMARK
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)
Spongostan Standard Absorbable Hemostatic Gelatin Sponge Spongostan Anal Absorbable Hemostatic Gelatin Sponge Spongostan Dental Absorbable Hemostatic Gelatin Sponge Spongostan Standard Absorbable Hemostatic Gelatin Sponge Spongostan Anal Absorbable Hemostatic Gelatin Sponge Spongostan Powder Absorbable Hemostatic Gelatin Powder
Model Identifier(s)
MS0002 MS0004 MS0005 MS0006 MS0007 MS0008