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Applied Medical Technology MiniONE® Capsule Non-Balloon Button - HSA Registration DE0508682

Access comprehensive regulatory information for Applied Medical Technology MiniONE® Capsule Non-Balloon Button in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508682 and owned by Applied Medical Technology, Inc. The device was registered on November 22, 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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CLASS C
DE0508682
Applied Medical Technology MiniONE® Capsule Non-Balloon Button
HSA Registration Number: DE0508682
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Product Description

The Low Profile Non-Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0508682
Registration Date
November 22, 2023
Retention Due Date
November 21, 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)
MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON MiniONE® Capsule NON-BALLOON
Model Identifier(s)
M1-2-1410 M1-2-1410-I M1-2-1412 M1-2-1412-I M1-2-1415 M1-2-1415-I M1-2-1417 M1-2-1417-I M1-2-1420 M1-2-1420-I M1-2-1425 M1-2-1425-I M1-2-1430 M1-2-1430-I M1-2-1812 M1-2-1812-I M1-2-1815 M1-2-1815-I M1-2-1817 M1-2-1817-I M1-2-1820 M1-2-1820-I M1-2-1824 M1-2-1824-I M1-2-1830 M1-2-1830-I M1-2-1834 M1-2-1834-I M1-2-1844 M1-2-1844-I M1-2-2017 M1-2-2017-I M1-2-2024 M1-2-2024-I M1-2-2034 M1-2-2034-I M1-2-2044 M1-2-2044-I M1-2-2417 M1-2-2417-I M1-2-2424 M1-2-2424-I M1-2-2434 M1-2-2434-I M1-2-2444 M1-2-2444-I