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Bien Air Surgery High Speed Burrs (Single use, sterile) - HSA Registration DE0510246

Access comprehensive regulatory information for Bien Air Surgery High Speed Burrs (Single use, sterile) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510246 and owned by Bien Air Surgery SA. The device was registered on January 16, 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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CLASS B
DE0510246
Bien Air Surgery High Speed Burrs (Single use, sterile)
HSA Registration Number: DE0510246
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Product Description

High speed burs are intended to cut and shape bones

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0510246
Registration Date
January 16, 2025
Retention Due Date
January 15, 2026
Product Owner
Short Name
Bien Air Surgery SA
Address
Rue de l'Ouest 2b,, 2340 Le Noirmont, SWITZERLAND
Registrant
Address
8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Importer
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #03-02, SINGAPORE 149555 8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Model Information
Model Name(s)
HS Stand. Burr, Ø2.3x70, 80k HS Stand. Burr, Ø2.3x125, 80k HS Stand. Burr, Ø2.3x95, 80k HS Stand. Burr, Ø3.1x70, 80k HS Stand. Burr, Ø3.1x150, 80k HS Stand. Burr, Ø3.1x125, 80k HS Stand. Burr, Ø3.1x95, 80k HS Stand. Burr, Ø4.0x70, 80k HS Stand. Burr, Ø4.0x150, 80k HS Stand. Burr, Ø4.0x125, 80k HS Stand. Burr, Ø4.0x95, 80k HS Stand. Burr, Ø5.0x70, 80k HS Stand. Burr, Ø5.0x150, 80k HS Stand. Burr, Ø5.0x125, 80k HS Stand. Burr, Ø5.0x95, 80k HS Stand. Burr, Ø6.0x70, 80k HS Stand. Burr, Ø6.0x125, 80k HS Stand. Burr, Ø7.0x70, 80k HS Diam. Burr, Ø1.0x70, 80k HS Diam. Burr, Ø1.0x150, 80k HS Diam. Burr, Ø1.0x125, 80k HS Diam. Burr, Ø1.0x95, 80k HS Diam. Burr, Ø1.8x150, 80k HS Diam. Burr, Ø2.0x70, 80k HS Diam. Burr, Ø2.3x125, 80k HS Diam. Burr, Ø2.3x95, 80k HS Diam. Burr, Ø2.5x70, 80k HS Diam. Burr, Ø3.1x70, 80k HS Diam. Burr, Ø3.1x150, 80k HS Diam. Burr, Ø3.1x125, 80k HS Diam. Burr, Ø3.1x95, 80k HS Diam. Burr, Ø4.0x70, 80k HS Diam. Burr, Ø4.0x150, 80k HS Diam. Burr, Ø4.0x125, 80k HS Diam. Burr, Ø5.0x70, 80k HS Dia.Burr,coarse,Ø2.3x70,80k HS Dia.Burr,coarse,Ø3.1x70,80k HS Dia.Bur,coarse,Ø3.1x150,80k HS Dia.Bur,coarse,Ø3.1x125,80k HS Dia.Burr,x-crse,Ø4.0x70,80k HS Dia.Bur,coarse,Ø4.0x150,80k HS Dia.Bur,coarse,Ø4.0x125,80k HS Dia.Burr,coarse,Ø4.0x95,80k HS Dia.Bur,coarse,Ø5.0x150,80k HS Dia.Bur,coarse,Ø5.0x125,80k HS Dia.Burr,coarse,Ø5.0x95,80k HS Craniotome Burr, long 80k HS Craniotome Burr,medium,80k HS Craniotome Burr, short, 80k HS Dia.Bur,x-crse,Ø4.7x125,80k
Model Identifier(s)
360123ES 360123M 360123S 360131ES 360131L 360131M 360131S 360140ES 360140L 360140M 360140S 360150ES 360150L 360150M 360150S 360160ES 360160M 360170ES 360210ES 360210L 360210M 360210S 360218L 360220ES 360223M 360223S 360225ES 360231ES 360231L 360231M 360231S 360240ES 360240L 360240M 360250ES 360323ES 360331ES 360331L 360331M 360340ES 360340L 360340M 360340S 360350L 360350M 360350S 362640L 362640M 362640S 363347M