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Huntleigh Hydroven 12 LymphAssist Professional - HSA Registration DE0503810

Access comprehensive regulatory information for Huntleigh Hydroven 12 LymphAssist Professional in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503810 and owned by Huntleigh Healthcare Limited. The device was registered on November 13, 2019.

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
DE0503810
Huntleigh Hydroven 12 LymphAssist Professional
HSA Registration Number: DE0503810
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Product Description

Intermittent Pneumatic Compression (IPC) is effective in the treatment of the following clinical conditions, when combined with an individualised monitoring programme: • Oedema - Dependent (including secondary to cerebrovascular incident, pregnancy or paralysis) - Traumatic (post-surgical or injury) • Lymphoedema - Primary and secondary (including post-surgery, radio or chemotherapy) • Chronic venous insufficiency • Post phlebotic syndrome • Acute and chronic wounds including venous leg ulcers and post-surgical wounds. IPC may also be beneficial in the management of: • Fixed flexion deformity • Lower limb pain due to trauma or surgery • Lipoedema Selection should be based upon a holistic assessment of the patients’ individual care needs.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0503810
Registration Date
November 13, 2019
Change Notification Approval Date
November 06, 2022
Retention Due Date
November 12, 2025
Product Owner
Short Name
Huntleigh Healthcare Limited
Address
35 Portmanmoor Road, Cardiff CF24 5HN, UNITED KINGDOM
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)
HYDROVEN 12 PUMP, INTERMITTENT PNEUMATIC COMPRESSION PUMP HYDROVEN 12, 68cm ARM GARMENT HYDROVEN 12, 78cm ARM GARMENT HYDROVEN 12, 68cm ARM INSERT HYDROVEN 12, 78cm ARM INSERT HYDROVEN 12, 76cm STANDARD LEG GARMENT HYDROVEN 12, 76cm WIDE LEG GARMENT HYDROVEN 12, 84cm STANDARD LEG GARMENT HYDROVEN 12, 84cm WIDE LEG GARMENT HYDROVEN 12, 76cm LEG INSERT HYDROVEN 12, 84cm LEG INSERT
Model Identifier(s)
316001 316A68 316A78 316AI68 316AI78 316L76S 316L76W 316L84S 316L84W 316LI76 316LI84