Singapore HSA registration DE0505390
GE CARESCAPE Respiratory Modules
Singapore·CLASS C·GE Finland Oy·Registered January 26, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0505390
- Registration Date
- January 26, 2021
- Change Notification Approval Date
- January 10, 2023
- Retention Due Date
- January 25, 2026
Product description
The CARESCAPE Respiratory Modules are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification, and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric, and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients. When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.
Product Owner
- Name
- GE Finland Oy
- Short Name
- GE Finland Oy
- Address
- Kourtaneenkatu 2, FI-00510 Helsinki, FINLAND
Registrant
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
- Model Name(s)
- D-lite++ Patient Spirometry Set, 2m/7ft D-lite++ Patient Spirometry Set, 3m/10ft Gas exhaust line, white conical and Colder, disposable, 1 m/3.3 ft Gas exhaust line, white conical and Colder, disposable, 0.18 m/7 in Gas exhaust line, white conical, disposable, 2 m/6.6 ft E-sCO-00 E-sCOV-00 E-sCAiOVX-00 E-sCAiO-00 E-sCAiOE-00 E-sCAiOV-00 E-sCAiOVE-00 E-sCOVX-00 D-lite sensor, Reusable Pedi-lite+ Sensor, Reusable Pedi-lite+ Sensor, Disposable Pediatric Spirometry Kit, Disposable, 2M Patient Spirometry Kit D-lite+ Spirometry Kit, adult, 3m/10ft Spirometry Tube, disposable, 3m/10ft D-Lite Spirometry Kit, adult, 3m/10ft Spirometry Tube, disposable, 2m/7ft Spirometry Tube, disposable, 6m/20ft D-lite+ sensor, Disposable Pediatric Spirometry Kit, Disposable, 3M D-fend Pro Water Trap, dark steel blue E-sCO-00 E-sCAiO-00 E-sCOV-00 E-sCAiOV-00 E-sCAiOVX-00 E-sCOVX-00 D-fend Pro+ Water Trap, green E-sCAiOVE-00 E-sCAiOE-00
- Model Identifier(s)
- 2104297-001 2104297-002 5514182 5514183 5514184 5696949 5697010 5697038 5697068 5697125 5697126 5697167 5697192 733910-HEL 73393 8001948 8002718 8004381 8004382 884101 889560 890031 891191-HEL 896952 M1032634 M1182629 M1184206 M1184207 M1184671 M1184847 M1199234 M1199507 M1200227 M1217240 M1226032
About this record
Access comprehensive regulatory information for GE CARESCAPE Respiratory Modules in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505390 and owned by GE Finland Oy. The device was registered on January 26, 2021.
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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