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De Soutter Sternudrive System - HSA Registration DE0504765

Access comprehensive regulatory information for De Soutter Sternudrive 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 DE0504765 and owned by De Soutter Medical Ltd. The device was registered on August 03, 2020.

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
DE0504765
De Soutter Sternudrive System
HSA Registration Number: DE0504765
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Product Description

Intended for use in surgical procedures involving the cutting of bone or hard tissue- specifically, for primary sternotomies. Additionally, MBC-709, DBR-700 and DBR-470 may be used for revision sternotomies.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0504765
Registration Date
August 03, 2020
Retention Due Date
August 02, 2025
Product Owner
Short Name
De Soutter Medical Ltd
Address
Halton Brook Business Park, Weston Road, Aston Clinton, Aylesbury, Buckinghamshire, HP22 5WF, UNITED KINGDOM
Registrant
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Importer
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Model Information
Model Name(s)
DBC-470 BATTERY STERNUM SAW - LESS GUARD DBR-700 REVISION STERNUM SAW (BL) MBC-709 STERNUDRIVE LITE MODULAR HANDPIECE DBR-470 PAEDIATRIC STERNUM SAW HANDPIECE CA-700 CHARGER MODULE FOR SB-701/702/SB-703/SB-704 BC-700 CHARGER - FITTED WITH CA-700 FOR SB-701/702/703/704 BC-700 CHARGER - FITTED WITH CA-703 FOR USE WITH AB-703/704 Sternum Guard 1/2 SIZE WIRE STERI-CASE & TRAY - 1 x DPC 1/2 SIZE WIRE STERI-TRAY - 1 x DPC SB-703 SMALL BATTERY - STERILIZABLE Li-Ion 13.2v SB-704 LARGE BATTERY - STERILIZABLE Li-Ion 13.2v 1/2 SIZE WIRE STERI-CASE & TRAY - 2 x SB-70x SERIES 1/2 SIZE WIRE STERI-TRAY - 2 x SB-70x SERIES KQ-709 SAGITTAL STERNUM SAW HEAD (S87) 1/2 SIZE WIRE STERI-TRAY - 1 x DBR-700 - STERILE 1/2 SIZE WIRE STERI-CASE & TRAY - 1 x DBR-700 - STERILE AB-703 BATTERY - ASEPTIC Li-Ion 10.9v AB-704 BATTERY - ASEPTIC Li-Ion 14.6v BC-706 CHARGER - SINGLE BAY - FOR USE WITH SB-703/704 BC-707 CHARGER - SINGLE BAY - FOR USE WITH AB-703 BC-708 CHARGER - SINGLE BAY - FOR USE WITH AB-704 AH-703 ASEPTIC HOUSING AH-704 ASEPTIC HOUSING AS-703 ASEPTIC SHIELD AS-704 ASEPTIC SHIELD 1/2 SIZE WIRE STERI-TRAY - 1 x DBC/DBR-470 - ASEPTIC Li-Ion 1/2 SIZE WIRE STERI-CASE & TRAY- 1 x DBC/R-470- ASPTC Li-Ion CQ-709 RECIPROCATING STERNUM SAW HEAD - LESS GUARD OQ-709 OSCILLATING STERNUM SAW HEAD NQ-709 PAEDIATRIC STERNUM SAW HEAD - (S88) 1/2 SIZE WIRE STERI-TRAY - 1 x DBR-700 - ASEPTIC Li-Ion 1/2 SIZE WIRE STERI-TRAY - 1 x MBC - STERILE 1/2 SIZE WIRE STERI-TRAY - 1 x DBC/DBR-470 - STERILE 1/2 SIZE WIRE STERI-CASE & TRAY- 1 x DBR-700- ASEPTIC Li-Ion 1/2 SIZE WIRE STERI-CASE & TRAY - 1 x MBC - STERILE 1/2 SIZE WIRE STERI-CASE & TRAY - 1 x DBC/DBR-470 - STERILE 1/2 SIZE WIRE STERI-CASE & TRAY - 1 x MBC - ASEPTIC Li-Ion 1/2 SIZE WIRE STERI-TRAY - 1 x MBC - ASEPTIC Li-Ion 1/2 SIZE STERILE FILTERED STERI-CASE -299 x 278 x 155mm BLUE DQ-709 DRILL - 4.0MM KEYED CHUCK WQ-709 WIRE/PIN DRIVER 0.7 - 4.0mm DQ-709 DRILL HEAD - SMALL AO OUTPUT MAINS CABLE BC/PS-UK PLUG STERNUM BLADE - DE SOUTTER SAGITTAL 64 x 23 x 1.00mm STERNUM BLADE - DE SOUTTER SAGITTAL 76 x 29 x 1.00mm STERNUM BLADE - DE SOUTTER SAGITTAL 64 x 23 x 1.00mm STERNUM BLADE - DE SOUTTER SAGITTAL 51 x 16.5 x 1.00mm STERNUM BLADE - DE SOUTTER SAGITTAL 66 x 48 x 1.00mm STERNUM BLADE - DE SOUTTER SAGITTAL 63 x 23 x 1.00mm STERNUM BLADE - DE SOUTTER SAGITTAL 93 x 41 x 1.00mm STERNUM BLADE - DE SOUTTER STANDARD GUARD 7 x 35 x 1.20mm STERNUM BLADE - DE SOUTTER STANDARD GUARD 7 x 35 x 1.20mm STERNUM BLADE - DE SOUTTER STANDARD GUARD 7 x 35 x 1.20mm STERNUM BLADE - DE SOUTTER SAGITTAL 50 x 65 x 0.80mm STERNUM BLADE - DE SOUTTER SAGITTAL 50 x 65 x 0.80mm STERNUM BLADE - DE SOUTTER SAGITTAL 50 x 23 x 0.90mm STERNUM BLADE - DE SOUTTER SAGITTAL 63 x 23 x 0.90mm STERNUM BLADE - DE SOUTTER SAGITTAL 82 x 35 x 1.00mm STERNUM BLADE - DE SOUTTER SAGITTAL 82 x 35 x 1.00mm STERNUM BLADE - DE SOUTTER SAGITTAL 50 x 23 x 0.90mm STERNUM BLADE - DE SOUTTER SAGITTAL 43 x 48 x 0.80mm SAGITTAL BLADE - DE SOUTTER PRISMATIC 50 x 65 x 0.60mm STERNUM BLADE - DE SOUTTER SAGITTAL 50 x 19 x 0.60mm STERNUM BLADE - DE SOUTTER SAGITTAL 63 x 19 x 0.60mm STERNUM BLADE - DE SOUTTER SAGITTAL 50 x 25 x 0.60mm STERNUM BLADE - DE SOUTTER SAGITTAL 63 x 25 x 0.60mm
Model Identifier(s)
1290224 1290884 1291554 1291664 15750 16220 16230 16490 17160 17170 17210 17220 17390 17400 17650 17880 17890 17910 17920 17990 18000 18010 18080 18090 18100 18110 18200 18210 18380 18420 18450 19070 19100 19110 19170 19200 19270 19280 19300 19370 19380 19390 19430 8290 S81-101 S81-102 S81-105 S81-106 S81-200 S81-201 S81-202 S84-400 S84-401 S84-402 S87-112 S87-113 S87-118 S87-119 S87-120 S87-121 S87-123 S87-125 S87-512 S88-908 S88-909 S88-918 S88-919