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Singapore HSA registration DE0507519

Boston Scientific Entrada™ Needle

Singapore flagSingapore·CLASS D·Boston Scientific Neuromodulation Corporation·Registered November 21, 2022
Device classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0507519
Registration Date
November 21, 2022
Change Notification Approval Date
May 19, 2023
Retention Due Date
November 20, 2025
Product description
The Entrada Needle with peelable sheath is required to insert the Infinion CX Lead and other compatible percutaneous Leads into the epidural or subcutaneous space.
Product Owner
Name
Boston Scientific Neuromodulation Corporation
Short Name
Boston Scientific Neuromodulation Corporation
Address
25155 Rye Canyon Loop Valencia, CA USA 91355, UNITED STATES
Registrant
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
Model Name(s)
Model SC-4220-45 Entrada™ Needle 11cm (4.5in) Model SC-4220-60 Entrada™ Needle 15cm (6.0in) Model SC-4220-S45 Entrada™ Spare Sheath 11cm (4.5 in) Model SC-4220-S60 Entrada™ Spare Sheath 15cm (6.0 in)
Model Identifier(s)
M365SC4220450 M365SC4220600 M365SC4220S450 M365SC4220S600
About this record

Access comprehensive regulatory information for Boston Scientific Entrada™ Needle in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507519 and owned by Boston Scientific Neuromodulation Corporation. The device was registered on November 21, 2022.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D