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T-Stat 2.0 Surface Sensor 2.5
EUDAMEDClass IIa (EU MDR)
Ref CTH-060-SUR 2.5Ref T-Stat 2.0
Identity
- Trade Name
- T-Stat EUDAMED
- Device Name
- T-Stat 2.0 Surface Sensor 2.5 EUDAMEDT-Stat 2.0 Microvascular Tissue Oximeter EUDAMED
- Model / Reference
- CTH-060-SUR 2.5 EUDAMEDT-Stat 2.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08511360070081 EUDAMED08511370070569 EUDAMED
- Basic UDI-DI
- B-08511360070081 EUDAMEDB-08511370070569 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMEDV0399 MEASUREMENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
T-Stat 2.0 Surface Sensor 2.5 by Spectros Medical Devices Inc — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08511360070081 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spectros Medical Devices Inc
- EUDAMED SRN
- US-MF-000049347
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fd4d7596-9b7a-4dcf-8cc5-0f774899fd7d 61 fields · synced Jul 18, 2026
- EUDAMED ab4d8930-b1fb-4c32-b0f7-7b1701c2eb85 61 fields · synced May 19, 2026