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Singapore HSA registration DE0508278

Integra Budde® Halo Retractor System

Singapore flagSingapore·CLASS B·Integra LifeSciences Corporation·Registered July 10, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0508278
Registration Date
July 10, 2023
Retention Due Date
July 09, 2025
Product description
The Budde® Halo Neurosurgical Retractor System was designed for use in all intracranial procedures where retraction of delicate brain tissue is required.
Product Owner
Name
Integra LifeSciences Corporation
Short Name
Integra LifeSciences Corporation
Address
4900 Charlemar Drive, Building A, Cincinnati, Ohio 45227, UNITED STATES
Registrant
Name
IDS MEDICAL SYSTEMS (SINGAPORE) PTE LTD
Address
1 KALLANG JUNCTION, Vanguard Campus, #05-01, SINGAPORE 339263
Importer
Name
IDS MEDICAL SYSTEMS (SINGAPORE) PTE LTD
Address
1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model information
Model Name(s)
TEW 2mm X 4-1/2" Hooked Micro TEW 2mm X 5-1/2" Hooked Micro TEW 2mm X 6-1/2" Hooked Micro TEW 2mm X 7-1/2" Hooked Micro TEW 4mm X 4-1/2" Hooked Micro TEW 4mm X 5-1/2" Hooked Micro TEW 4mm X 6-1/2" Hooked Micro TEW 4mm X 7-1/2" Hooked Micro BUDDE 1/8" - 3/8" x 5" Tapered BUDDE 13/64" - 5/8" x 5" Tapered BUDDE 1/4" - 3/4" x 5" Tapered BUDDE 5/16" - 1" x 5" Tapered TEW 2mm X 4-1/2" Serrated Micro TEW 2mm X 5-1/2" Serrated Micro TEW 2mm X 6-1/2" Serrated Micro TEW 2mm X 7-1/2" Serrated Micro TEW 4mm X 4-1/2" Serrated Micro TEW 4mm X 5-1/2" Serrated Micro TEW 4mm X 6-1/2" Serrated Micro TEW 4mm X 7-1/2" Serrated Micro BUDDE HALO RETRACTOR BUDDE HALO RETRACTOR SIDE RAIL SUPPORT BUDDE HALO RADIOLUCENT RETRACTOR
Model Identifier(s)
438A1151A 438A1151B 438A1151C 438A1151D 438A1152A 438A1152B 438A1152C 438A1152D 438A1154B 438A1154C 438A1154D 438A1154E 438A1155A 438A1155B 438A1155C 438A1155D 438A1157A 438A1157B 438A1157C 438A1157D A1040 A1067 A1096
About this record

Access comprehensive regulatory information for Integra Budde® Halo Retractor System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508278 and owned by Integra LifeSciences Corporation. The device was registered on July 10, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B