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AJJ Urinary Catheters for Single Use (Foley) - HSA Registration DE0509817

Access comprehensive regulatory information for AJJ Urinary Catheters for Single Use (Foley) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509817 and owned by AJJ Healthcare Management Pte Ltd. The device was registered on September 19, 2024.

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 C
DE0509817
AJJ Urinary Catheters for Single Use (Foley)
HSA Registration Number: DE0509817
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Product Description

The product is intended to continuous urinate and douche urinary bladder by inserting into urinary bladder though urethra. Indications: 1. Two-way catheters is used for routine urethral catheterization; 2. Three-way catheters is used for irrigation after surgery, such as calculi. 3. The catheters of tiemann tip, used for patients with enlargement of the prostate, to find the angle for easy insertion.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509817
Registration Date
September 19, 2024
Retention Due Date
September 18, 2025
Product Owner
Short Name
AJJ Healthcare Management Pte Ltd
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #02-04, SINGAPORE 149555
Registrant
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #02-04, SINGAPORE 149555
Importer
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #02-04, SINGAPORE 149555
Model Information
Model Name(s)
2 Way Silicone Foley Catheter,with Normal Balloon,6Fr 2 Way Silicone Foley Catheter,with Normal Balloon,8Fr 2 Way Silicone Foley Catheter,with Integral Flat Balloon,8Fr 2 Way Silicone Foley Catheter,with Normal Balloon,10Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Normal Balloon,10Fr 2 Way Silicone Foley Catheter,with Integral Flat Balloon,10Fr 2 Way Silicone Foley Catheter,with Normal Balloon,12Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Normal Balloon,12Fr 2 Way Silicone Foley Catheter,with Integral Flat Balloon,12Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Integral Flat Balloon,12Fr 2 Way Silicone Foley Catheter,with Normal Balloon,14Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Normal Balloon,14Fr 2 Way Silicone Foley Catheter,with Integral Flat Balloon,14Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Integral Flat Balloon,14Fr 2 Way Silicone Foley Catheter,with Normal Balloon,16Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Normal Balloon,16Fr 2 Way Silicone Foley Catheter,with Integral Flat Balloon,16Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Integral Flat Balloon,16Fr 2 Way Silicone Foley Catheter,with Normal Balloon,18Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Normal Balloon,18Fr 2 Way Silicone Foley Catheter,with Integral Flat Balloon,18Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Integral Flat Balloon,18Fr 2 Way Silicone Foley Catheter,with Normal Balloon,20Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Normal Balloon,20Fr 2 Way Silicone Foley Catheter,with Integral Flat Balloon,20Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Integral Flat Balloon,20Fr 2 Way Silicone Foley Catheter,with Normal Balloon,22Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Normal Balloon,22Fr 2 Way Silicone Foley Catheter,with Integral Flat Balloon,22Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Integral Flat Balloon,22Fr 2 Way Silicone Foley Catheter,with Normal Balloon,24Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Normal Balloon,24Fr 2 Way Silicone Foley Catheter,with Integral Flat Balloon,24Fr 2 Way Silicone Foley Catheter with Tiemann Tip, with Integral Flat Balloon,24Fr 3 Way Silicone Foley Catheter,with Normal Balloon,14Fr 3 Way Silicone Foley Catheter,with Integral Flat Balloon,14Fr 3 Way Silicone Foley Catheter,with Normal Balloon,16Fr 3 Way Silicone Foley Catheter,with Integral Flat Balloon,16Fr 3 Way Silicone Foley Catheter,with Normal Balloon,18Fr 3 Way Silicone Foley Catheter,with Integral Flat Balloon,18Fr 3 Way Silicone Foley Catheter,with Normal Balloon,20Fr 3 Way Silicone Foley Catheter,with Integral Flat Balloon,20Fr 3 Way Silicone Foley Catheter,with Normal Balloon,22Fr 3 Way Silicone Foley Catheter,with Integral Flat Balloon,22Fr 3 Way Silicone Foley Catheter,with Normal Balloon,24Fr 3 Way Silicone Foley Catheter,with Integral Flat Balloon,24Fr 3 Way Silicone Foley Catheter,with Normal Balloon,26Fr
Model Identifier(s)
AJJ-GTC-2FC-06XXXS AJJ-GTC-2FC-08XXXS AJJ-GTC-2FC-08XXXSI AJJ-GTC-2FC-10XXXS AJJ-GTC-2FC-10XXXS-TM AJJ-GTC-2FC-10XXXSI AJJ-GTC-2FC-12XXXS AJJ-GTC-2FC-12XXXS-TM AJJ-GTC-2FC-12XXXSI AJJ-GTC-2FC-12XXXSI-TM AJJ-GTC-2FC-14XXXS AJJ-GTC-2FC-14XXXS-TM AJJ-GTC-2FC-14XXXSI AJJ-GTC-2FC-14XXXSI-TM AJJ-GTC-2FC-16XXXS AJJ-GTC-2FC-16XXXS-TM AJJ-GTC-2FC-16XXXSI AJJ-GTC-2FC-16XXXSI-TM AJJ-GTC-2FC-18XXXS AJJ-GTC-2FC-18XXXS-TM AJJ-GTC-2FC-18XXXSI AJJ-GTC-2FC-18XXXSI-TM AJJ-GTC-2FC-20XXXS AJJ-GTC-2FC-20XXXS-TM AJJ-GTC-2FC-20XXXSI AJJ-GTC-2FC-20XXXSI-TM AJJ-GTC-2FC-22XXXS AJJ-GTC-2FC-22XXXS-TM AJJ-GTC-2FC-22XXXSI AJJ-GTC-2FC-22XXXSI-TM AJJ-GTC-2FC-24XXXS AJJ-GTC-2FC-24XXXS-TM AJJ-GTC-2FC-24XXXSI AJJ-GTC-2FC-24XXXSI-TM AJJ-GTC-3FC-14XXXS AJJ-GTC-3FC-14XXXSI AJJ-GTC-3FC-16XXXS AJJ-GTC-3FC-16XXXSI AJJ-GTC-3FC-18XXXS AJJ-GTC-3FC-18XXXSI AJJ-GTC-3FC-20XXXS AJJ-GTC-3FC-20XXXSI AJJ-GTC-3FC-22XXXS AJJ-GTC-3FC-22XXXSI AJJ-GTC-3FC-24XXXS AJJ-GTC-3FC-24XXXSI AJJ-GTC-3FC-26XXXS