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Singapore HSA registration DE0008387

GE CARESCAPE Life Upgrade Program for SPI Software

Singapore flagSingapore·CLASS C·GE Finland Oy·Registered February 08, 2012
Device classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
HSA Product Code
HSAMDC00104
HS Code
90189030
Registration information
Registration Number
DE0008387
Registration Date
February 08, 2012
Retention Due Date
February 07, 2026
Product description
The Surgical Pleth Index (SPI) is a parameter that reacts to hemodynamic responses caused by surgical stimuli and analgesic medications. SPI is based on the plethysmographic pulse amplitude and pulse interval. The SPI measurement is to be used for unconscious and fully anesthetized adult (>18 years old) patients during general anesthesia.
Product Owner
Name
GE Finland Oy
Short Name
GE Finland Oy
Address
Kourtaneenkatu 2, FI-00510 Helsinki, FINLAND
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD. GE PACIFIC HOLDINGS PTE. LTD. GE PACIFIC PRIVATE LIMITED
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model information
Model Name(s)
CARESCAPE Monitor B850 Surgical Pleth Index (SPI) Software License Software Option CARESCAPE Monitor B850 Surgical Pleth Index (SPI) Software License Software Option CARESCAPE Monitor B850 Surgical Pleth Index (SPI) Software License Software Option
Model Identifier(s)
M1175209 M1175248 M1175836
About this record

Access comprehensive regulatory information for GE CARESCAPE Life Upgrade Program for SPI Software in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0008387 and owned by GE Finland Oy. The device was registered on February 08, 2012.

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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