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Temperature probe
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref TS-IFN-PG30510(k) K173194
Identity
- Trade Name
- Temperature probe EUDAMED
- Device Name
- Temperature probe EUDAMED
- Model / Reference
- TS-IFN-PG30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970706367155 EUDAMED
- Basic UDI-DI
- B-06970706367155 EUDAMED
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose patient temperature probe, reusable
Temperature probe by Orantech Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173194 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970706367155 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- FDA Applicant
- Orantech, Inc.
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (2)
- EUDAMED c6184db5-ebae-47bb-b387-a1337849f842 85 fields · synced Jun 18, 2026
- FDA 510(k) K173194 1 fields · synced May 18, 2026