Identity
- Device Name
- T-Stat 2.0 Endoscopic Sensor EUDAMED
- Model / Reference
- CTH-060-ENDO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08511360070227 EUDAMED
- Basic UDI-DI
- B-08511360070227 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
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
T-Stat 2.0 Endoscopic Sensor by Spectros Medical Devices Inc — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08511360070227 | 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 (1)
- EUDAMED 120c19c3-99d5-40fc-8592-fae93a8fb1c8 61 fields · synced Jul 10, 2026