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Reusable skin temperature probe
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 011-01405Model SPR-275PHA
Identity
- Device Name
- Reusable skin temperature probe EUDAMED
- Model / Reference
- SPR-275PHA EUDAMED011-01405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260651380449 EUDAMED
- Basic UDI-DI
- B-04260651380449 EUDAMED
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose patient temperature probe, reusable
Reusable skin temperature probe by Sensatronic GmbH — 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 | K203643 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04260651380449 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sensatronic GmbH
- EUDAMED SRN
- DE-MF-000004927
Sources (2)
- EUDAMED f4541683-4ab7-451d-ba8a-7b0f89b7428a 61 fields · synced Jul 11, 2026
- FDA 510(k) K203643 1 fields · synced May 18, 2026