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HSA · registration DE0509094

RAUMEDIC® RAUMED® NeuroSmart Patient Monitor

SingaporeNeurologyClass DRaumedic AG
Official record identity
Registration number
DE0509094
Model name
Spliceable Tunneling Sleeve CH8; Spliceable Tunneling Sleeve CH12; NPS 2 Datex; NEUROVENT VP; NEUROVENT-PX; NPS 3; RAUMEDIC Drill KIT CH 9; NEUROVENT IFD-S; RAUMEDIC Bolt KIT CH 9; NPS 2 Space Labs; NPS 2 Spiegelberg CPP; RAUMEDIC Bolt KIT CH 5; RAUMEDIC Drill KIT CH 5; BOLT-DRILL KIT CH5; BOLT-DRILL KIT CH9; NPS 2 Codman; BOLT-DRILL KIT PTO; NPS 2 Hellige; NPS 2 Siemens/ Drager Infinity; NPS 2 Philips/HP; NEUROVENT- P; NEUROVENT; BOLT-DRILL KIT VP 16; NEURODUR; NPS 2 GE/ Marquette; NPS2 GE; ICP-TEMP-Adapter Philips/HP; NEUROVENT- P- TEMP; NEUROVENT - TEMP; NEUROVENT Temp IFD-S; NEURODUR - TEMP; ICP-TEMP-Adapter; ICP-Temp Cable; NPS 2 Schiller; NPS 2 Schiller Argus Pro; NPS 2 Braun VISICON; NEUROVENT 6 F; NPS 2 Nihon Kohden BSM 41xx; Cable DATALOGGER GE/Marquette; Cable DATALOGGER Philips/HP; Cable DATALOGGER Siemens/Dräger Infinity; Cable Datex; Transducercable DATALOGGER Smiths Medical; Cable DATALOGGER Space Labs; NEUROVENT-PTO; Cable DATALOGGER Nihon Kohden 41xx; NPS2 SpaceLabs 9X496 Module; NPS 2 Petas; ICP-Temp adapter 2m long; RAUMED NeuroSmart; RAUMED NeuroSmart logO; NEUROVENT-PTO 2L BOLT; NEUROVENT IFD-R; NEUROVENT TEMP IFD-R; Cable PTO; Cable LWL; NEUROVENT-TO; NPS 2 FUKUDA DENSHI; NPS 2 Spiegelberg Compliance; BOLT KIT PTO; Transducercable DATALOGGER Edwards TRUWAVE; Transducercable DATALOGGER Becton Dickinson; BOLT KIT PTO-2L; Transducer cable pvb xtrans; NEUROVENT P-tel; NEUROVENT-VP16; RALK Hand drill; Siemens temperatur adapter; Adapter Siemens 10-7 pin; USB cable; Static fixation; Table fixation; PC software MPR; Wide Range Power Adapter MPR1/2; Power Supply NeuroSmart
Model identifier
090516-002; 090727-001; 090924-001; 091576-001; 091580-001; 091656-001; 091668-002; 091678-001; 091688-002; 091715-001; 091738-001; 091868-002; 091878-002; 091888-001; 091898-001; 091978-001; 092380-001; 092617-001; 092627-001; 092637-001; 092946-001; 092956-001; 092969-001; 092976-001; 093807-001; 093999-001; 094047-001; 094268-001; 094278-001; 094288-001; 094298-001; 094323-001; 094328-001; 094527-001; 094613-001; 094624-001; 094678-001; 094716-001; 094858-001; 094868-002; 094878-002; 094888-001; 094908-001; 094967-001; 095008-002; 095017-001; 095027-002; 095206-001; 095216-001; 095284-001; 095294-001; 095308-001; 095317-001; 095327-001; 095624-001; 095657-001; 095908-002; 096003-001; 096013-001; 096026-001; 096036-001; 096046-001; 096076-001; 096494-001; 096504-001; 096704-001; 231584-002; 235526-001; 248214-001; 283949-001; 283957-001; 283959-001; 283962-001; 284027-001; 284037-001
Registration date
March 22, 2024
Classification
Risk class
Class D
Official value: CLASS D
Published category
Neurology
Published parties
Product owner
Raumedic AG
Registrant / registration holder
HUMEDICAL (S) PTE. LTD.
Official description

The NeuroSmart is a diagnostic device and is used for monitoring up to four invasively measured physiological pressures and up to two patient temperatures (with alarm function). In addition to measuring and monitoring the aforementioned vital parameters, the NeuroSmart offers long-term storage of the readings. The NeuroSmart may only be used on a single patient at the same time.

Additional source fields
Product owner address
Hermann-Stadinger-Strasse 2, 95233 Helmbrechts, Germany
Registrant address
3791 JALAN BUKIT MERAH, #06-17, E-CENTRE @ REDHILL, Singapore 159471
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.