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Reusable Skin Temperature Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 081209Model 409B
Identity
- Trade Name
- Reusable Skin Temperature Probe EUDAMEDFDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Device Name
- Reusable Skin Temperature Probe, Attached Surface EUDAMEDReusable Temperature Probe – Skin (Adult) FDA UDI
- Model / Reference
- 409B EUDAMEDFDA UDI081209 EUDAMED
- Description
- Reusable Temperature Probe – Skin (Adult) FDA UDI
Identifiers
- Catalog Number
- 081209 FDA UDI
- Primary DI / UDI-DI
- D-H297409B08K EUDAMEDH297409B0 FDA UDI
- Basic UDI-DI
- B-H297409B08K EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010299 BODY TEMPERATURE MONITORING PROBES - OTHER EUDAMED
- GMDN Term
- General-purpose patient temperature probe, reusable 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
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Reusable Skin 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European Union No Longer Active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| EUDAMED | European Union | CE/MDD | B-H297409B08K | Class IIa | No Longer Active |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 1a5ff446-c828-470e-802a-3ffacfe956fd 61 fields · synced Sep 18, 2026
- FDA UDI 2d7fe962-19c5-46ed-aff5-89d03f1b5540 36 fields · synced May 30, 2026