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ARJOHUNTLEIGH FLOWTRON ACS900 - HSA Registration DE0017857

Access comprehensive regulatory information for ARJOHUNTLEIGH FLOWTRON ACS900 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017857 and owned by ArjoHuntleigh AB. The device was registered on February 05, 2016.

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 B
DE0017857
ARJOHUNTLEIGH FLOWTRON ACS900
HSA Registration Number: DE0017857
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Product Description

The intended use of this product is to prevent Deep Vein Thrombosis (DVT). The garments are single patient use only.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0017857
Registration Date
February 05, 2016
Change Notification Approval Date
April 03, 2023
Retention Due Date
February 04, 2026
Product Owner
Short Name
ArjoHuntleigh AB
Address
Hans Michelsensgatan 10, 211 20 Malmo, SWEDEN
Registrant
Address
31 KAKI BUKIT ROAD 3, TECHLINK LOBBY B, #05-06/07, SINGAPORE 417818
Importer
Address
31 KAKI BUKIT ROAD 3, TECHLINK, #05-06/07, SINGAPORE 417818
Model Information
Model Name(s)
Flowtron ACS900 Flowtron ACS900 DVT10 DVT20 DVT30 DVT40 DVT60L FG100 FG200 L501-M L503-M TRP10 TRP20 TRP30 TRP40 TRP60L
Model Identifier(s)
526000-03 526000-04 DVT10 DVT20 DVT30 DVT40 DVT60L FG100 FG200 L501-M L503-M TRP10 TRP20 TRP30 TRP40 TRP60L