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Foley Cataheter Temperature Probe (4400 Series)
EUDAMEDClass IIb (EU MDR)
Ref SP21585-4466
Identity
- Trade Name
- Foley Cataheter Temperature Probe (4400 Series) EUDAMED
- Device Name
- Physio Controls Sterile Foley Catheter Temperature Probe, 16Fr, Orange EUDAMED
- Model / Reference
- SP21585-4466 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SP21585-446653 EUDAMED
- Basic UDI-DI
- B-SP21585-446653 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 Cataheter 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European Union No Longer Active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| EUDAMED | European Union | CE/MDD | B-SP21585-446653 | Class IIb | No Longer Active |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 d9cf0ca9-0b82-4a35-b442-d47c2d1876d4 61 fields · synced Jul 9, 2026