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Foley Catheter Temperature Probe (4400 Series)
EUDAMEDClass IIb (EU MDR)
Ref SP21585-4464
Identity
- Trade Name
- Foley Catheter Temperature Probe (4400 Series) EUDAMED
- Device Name
- Physio Controls Sterile Foley Catheter Temperature Probe, 14 Fr, Green EUDAMED
- Model / Reference
- SP21585-4464 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SP21585-44644X EUDAMED
- Basic UDI-DI
- B-SP21585-44644X EUDAMED
- EMDN Code
- V03010299 BODY TEMPERATURE MONITORING PROBES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Foley Catheter Temperature Probe (4400 Series) by Measurement Specialties, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-SP21585-44644X | Class IIb | No Longer Active |
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Manufacturer
- Manufacturer
- Measurement Specialties Inc.
- EUDAMED SRN
- US-MF-000006309
- Authorised Representative
- MEAS Ireland IE-AR-000005162
Sources (1)
- EUDAMED 3e05fcbd-10a5-4077-865d-533f344c4d49 61 fields · synced Jul 10, 2026