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MEAS 4400 Series Temperature Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 861553Model 4499HD
Identity
- Trade Name
- MEAS 4400 Series Temperature Probe EUDAMEDFDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- Sterile Skin Temperature Probes (4499 Variant) EUDAMEDTemperature Probe FDA UDI
- Model / Reference
- 4499HD EUDAMEDFDA UDI861553 EUDAMED
- Description
- Temperature Probe FDA UDI
Identifiers
- Catalog Number
- 861553 FDA UDI
- Primary DI / UDI-DI
- D-H2974499HD0L8 EUDAMEDH2974499HD0 FDA UDI
- Basic UDI-DI
- B-H2974499HD0L8 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010299 BODY TEMPERATURE MONITORING PROBES - OTHER EUDAMED
- GMDN Term
- General-purpose patient temperature probe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MEAS 4400 Series Temperature Probe by Measurement Specialties, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-H2974499HD0L8 | Class IIa | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Measurement Specialties Inc.
- EUDAMED SRN
- US-MF-000006309
- Authorised Representative
- MEAS Ireland IE-AR-000005162
Sources (2)
- EUDAMED 2494553f-3bc5-4027-ba75-20bfe85c6f7f 61 fields · synced Jul 12, 2026
- FDA UDI d50e333b-7266-4425-8f6f-bba314a62468 36 fields · synced May 30, 2026