Singapore HSA registration DE0508626
Applied Medical Technology Capsule Pre-loaded Replacement Gastrostomy Tube
Singapore·CLASS C·Applied Medical Technology, Inc·Registered November 03, 2023Device 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 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.
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
About this record
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.
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