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MIDSleeve, Gastric calibration tube for sleeve gastrectomy - HSA Registration DE0012239

Access comprehensive regulatory information for MIDSleeve, Gastric calibration tube for sleeve gastrectomy in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0012239 and owned by Medical Innovation Developpement. The device was registered on January 31, 2013.

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 B
DE0012239
MIDSleeve, Gastric calibration tube for sleeve gastrectomy
HSA Registration Number: DE0012239
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Product Description

MIDSLEEVE is a surgical accessory for the bariatric surgery procedure (sleeve gastrectomy). It is inserted into the stomach via the patient's mouth and oesophagus. The balloon is inflated with air using a syringe, via the valve. The volume injected into the balloon is used to calibrate the volume of the residual gastric antrum. MIDSLEEVE can also be connected to a suction system to remove any air or fluids from the patientโ€™s stomach.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00110
HS Code
90189090
Registration Information
Registration Number
DE0012239
Registration Date
January 31, 2013
Retention Due Date
January 30, 2026
Product Owner
Short Name
Medical Innovation
Address
9, chemin du Jubin, 69570 Dardilly, FRANCE
Registrant
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model Information
Model Name(s)
MIDSLEEVE
Model Identifier(s)
MID160