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Singapore HSA registration DE0510207

Spectros T-Stat 2.0 Microvascular Tissue Oximeter with accessories

Singapore flagSingapore·CLASS B·Spectros Medical Devices, Inc.·Registered January 03, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0510207
Registration Date
January 03, 2025
Retention Due Date
January 02, 2026
Product description
The Spectros T-Stat 2.0 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states. The prospective clinical value of measurements made with the T-Stat Oximeter has not been demonstrated in disease states. The T-Stat Oximeter should not be used as the sole basis diagnosis or therapy.
Product Owner
Name
Spectros Medical Devices, Inc.
Short Name
Spectros Medical Devices, Inc.
Address
2211 Norfolk St. STE 1110, Houston, Texas, 77098, UNITED STATES
Registrant
Name
HUMEDICAL (S) PTE. LTD.
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Importer
Name
HUMEDICAL (S) PTE. LTD.
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Model information
Model Name(s)
2.5 cm Surface Sensor CTH-060-SUR 2.5CM 1 cm Surface Sensor CTH-060-SUR 1CM, box of 5 1 cm Surface Sensor CTH-060-SUR 1CM 2.3m Endoscopic Sensor CTH-060-ENDO, box of 5 2.3m Endoscopic Sensor CTH-060-ENDO Oral Sensor CTH-060-ORA M, box of 5 Oral Sensor CTH-060-ORA M T-Stat 2.0 2.5 cm Surface Sensor CTH-060-SUR 2.5CM, box of 5
Model Identifier(s)
851136007001 851136007015 851136007018 851136007022 851136007025 851136007046 851136007049 851136007056 861136007008
About this record

Access comprehensive regulatory information for Spectros T-Stat 2.0 Microvascular Tissue Oximeter with accessories in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510207 and owned by Spectros Medical Devices, Inc.. The device was registered on January 03, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B