Pure Global

Applied Medical Technology Capsule Pre-loaded Replacement Gastrostomy Tube - HSA Registration DE0508626

Access comprehensive regulatory information for Applied Medical Technology Capsule Pre-loaded Replacement Gastrostomy Tube in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508626 and owned by Applied Medical Technology, Inc. The device was registered on November 03, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0508626
Applied Medical Technology Capsule Pre-loaded Replacement Gastrostomy Tube
HSA Registration Number: DE0508626
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Monarch® / Dome G-Tube (Pre-Loaded Replacement G-Tube – with Capsule) is to be used as a percutaneous replacement gastrostomy tube for a patient with a well established gastrostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a patient who is unable to consume nutrition by conventional means. The Monarch® / Dome G-Tube can also deliver medication and allow for decompression of the stomach.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0508626
Registration Date
November 03, 2023
Retention Due Date
November 02, 2025
Product Owner
Short Name
Applied Medical Technology, Inc
Address
8006 Katherine Boulevard, Brecksville, OH 44141, UNITED STATES
Registrant
Address
300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Importer
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Model Information
Model Name(s)
Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Dome™ Pre-loaded Replacement Gastrostomy Tube Capsule Dome™ Pre-loaded Replacement Gastrostomy Tube Capsule Dome™ Pre-loaded Replacement Gastrostomy Tube Capsule Dome™ Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Monarch® Pre-loaded Replacement Gastrostomy Tube Capsule Dome™ Pre-loaded Replacement Gastrostomy Tube Capsule Dome™ Pre-loaded Replacement Gastrostomy Tube Capsule Dome™ Pre-loaded Replacement Gastrostomy Tube Capsule Dome™ Pre-loaded Replacement Gastrostomy Tube
Model Identifier(s)
9-C1210 9-C1210-I 9-C1410 9-C1410-I 9-C1810 9-C1810-I 9-C2010 9-C2010-I 9-C2020 9-C2020-I 9-C2420 9-C2420-I 9-CG1210 9-CG1210-I 9-CG1410 9-CG1410-I 9-CG1810 9-CG1810-I 9-CG2010 9-CG2010-I 9-CG2020 9-CG2020-I 9-CG2420 9-CG2420-I