Pure Global

Applied Medical Technology MINI ONE® Balloon Button - HSA Registration DE0507917

Access comprehensive regulatory information for Applied Medical Technology MINI ONE® 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 DE0507917 and owned by Applied Medical Technology, Inc. The device was registered on March 17, 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
DE0507917
Applied Medical Technology MINI ONE® Balloon Button
HSA Registration Number: DE0507917
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Product Description

The Low Profile 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. The Low Profile Balloon Feeding Device is intended for all age groups.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0507917
Registration Date
March 17, 2023
Retention Due Date
March 16, 2026
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)
MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit® MINI ONE® Balloon Button Kit MINI ONE® Balloon Button Kit-ENFit®
Model Identifier(s)
M1-5-1208 M1-5-1208-I M1-5-1210 M1-5-1210-I M1-5-1212 M1-5-1212-I M1-5-1215 M1-5-1215-I M1-5-1217 M1-5-1217-I M1-5-1220 M1-5-1220-I M1-5-1223 M1-5-1223-I M1-5-1225 M1-5-1225-I M1-5-1227 M1-5-1227-I M1-5-1230 M1-5-1230-I M1-5-1235 M1-5-1235-I M1-5-1240 M1-5-1240-I M1-5-1408 M1-5-1408-I M1-5-1410 M1-5-1410-I M1-5-1412 M1-5-1412-I M1-5-1415 M1-5-1415-I M1-5-1417 M1-5-1417-I M1-5-1420 M1-5-1420-I M1-5-1423 M1-5-1423-I M1-5-1425 M1-5-1425-I M1-5-1427 M1-5-1427-I M1-5-1430 M1-5-1430-I M1-5-1435 M1-5-1435-I M1-5-1440 M1-5-1440-I M1-5-1444 M1-5-1444-I M1-5-1450 M1-5-1450-I M1-5-1455 M1-5-1455-I M1-5-1460 M1-5-1460-I M1-5-1465 M1-5-1465-I M1-5-1610 M1-5-1610-I M1-5-1612 M1-5-1612-I M1-5-1615 M1-5-1615-I M1-5-1617 M1-5-1617-I M1-5-1620 M1-5-1620-I M1-5-1623 M1-5-1623-I M1-5-1625 M1-5-1625-I M1-5-1627 M1-5-1627-I M1-5-1630 M1-5-1630-I M1-5-1635 M1-5-1635-I M1-5-1640 M1-5-1640-I M1-5-1644 M1-5-1644-I M1-5-1650 M1-5-1650-I M1-5-1655 M1-5-1655-I M1-5-1660 M1-5-1660-I M1-5-1810 M1-5-1810-I M1-5-1812 M1-5-1812-I M1-5-1815 M1-5-1815-I M1-5-1817 M1-5-1817-I M1-5-1820 M1-5-1820-I M1-5-1823 M1-5-1823-I M1-5-1825 M1-5-1825-I M1-5-1827 M1-5-1827-I M1-5-1830 M1-5-1830-I M1-5-1835 M1-5-1835-I M1-5-1840 M1-5-1840-I M1-5-1844 M1-5-1844-I M1-5-1850 M1-5-1850-I M1-5-1855 M1-5-1855-I M1-5-1860 M1-5-1860-I M1-5-2010 M1-5-2010-I M1-5-2012 M1-5-2012-I M1-5-2015 M1-5-2015-I M1-5-2017 M1-5-2017-I M1-5-2020 M1-5-2020-I M1-5-2023 M1-5-2023-I M1-5-2025 M1-5-2025-I M1-5-2027 M1-5-2027-I M1-5-2030 M1-5-2030-I M1-5-2035 M1-5-2035-I M1-5-2040 M1-5-2040-I M1-5-2044 M1-5-2044-I M1-5-2050 M1-5-2050-I M1-5-2055 M1-5-2055-I M1-5-2060 M1-5-2060-I M1-5-2415 M1-5-2415-I M1-5-2417 M1-5-2417-I M1-5-2420 M1-5-2420-I M1-5-2423 M1-5-2423-I M1-5-2425 M1-5-2425-I M1-5-2427 M1-5-2427-I M1-5-2430 M1-5-2430-I M1-5-2435 M1-5-2435-I M1-5-2440 M1-5-2440-I M1-5-2444 M1-5-2444-I M1-5-2450 M1-5-2450-I M1-5-2455 M1-5-2455-I M1-5-2460 M1-5-2460-I