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Singapore HSA registration DE0508467

Applied Medical Technology AMT Balloon G-Tube Replacement Gastrostomy Feeding Device

Singapore flagSingapore·CLASS C·Applied Medical Technology, Inc·Registered September 08, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0508467
Registration Date
September 08, 2023
Retention Due Date
September 07, 2025
Product description
The AMT Balloon G-Tube is to be used as a percutaneous replacement gastrostomy tube for a patient with a well-established gas-trostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. The AMT Balloon G-Tube can also deliver medication and allow for decompression of the stomach.
Product Owner
Name
Applied Medical Technology, Inc
Short Name
Applied Medical Technology, Inc
Address
8006 Katherine Boulevard, Brecksville, OH 44141, UNITED STATES
Registrant
Name
ANDAMAN MEDICAL PTE. LTD.
Address
300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Importer
Name
Bluestone Corporation Pte Ltd
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Model information
Model Name(s)
AMT Balloon G-Tube with Medication Port AMT Balloon G-Tube with ENFit® Port AMT Balloon G-Tube with Medication Port AMT Balloon G-Tube with ENFit® Port AMT Balloon G-Tube with Medication Port AMT Balloon G-Tube with ENFit® Port AMT Balloon G-Tube with Medication Port AMT Balloon G-Tube with ENFit® Port AMT Balloon G-Tube with Medication Port AMT Balloon G-Tube with ENFit® Port AMT Balloon G-Tube with Medication Port AMT Balloon G-Tube with ENFit® Port
Model Identifier(s)
7-1210 7-1210-I 7-1410 7-1410-I 7-1610 7-1610-I 7-1810 7-1810-I 40360 7-2010-I 186457 7-2410-I
About this record

Access comprehensive regulatory information for Applied Medical Technology AMT Balloon G-Tube Replacement Gastrostomy Feeding Device in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508467 and owned by Applied Medical Technology, Inc. The device was registered on September 08, 2023.

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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