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Singapore HSA registration DE0510402

NuMED Atrioseptostomy Catheter

Singapore flagSingapore·CLASS D·NuMED, Inc·Registered February 28, 2025
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0510402
Registration Date
February 28, 2025
Retention Due Date
February 27, 2026
Product description
Recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. Balloon atrioseptostomy is performed in conjunction with diagnostic cardiac catheterization and has been carried out after the diagnosis of several congenital cardiac defects: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.
Product Owner
Name
NuMED, Inc
Short Name
NuMED
Address
2880 Main Street, Hopkinton, New York 12965, UNITED STATES
Registrant
Name
SOMNOTEC (S) PTE. LTD.
Address
37 UBI CRESCENT, SINGAPORE 408586
Importer
Name
SOMNOTEC (S) PTE. LTD.
Address
37 UBI CRESCENT, SINGAPORE 408586
Model information
Model Name(s)
Z-5 Atrioseptostomy catheter Z-5 Atrioseptostomy catheter Z-6 Atrioseptostomy catheter Z-6 Atrioseptostomy catheter
Model Identifier(s)
SPT002 SPT003 Z6135 Z695
About this record

Access comprehensive regulatory information for NuMED Atrioseptostomy Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510402 and owned by NuMED, Inc. The device was registered on February 28, 2025.

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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