Identity
- Trade Name
- TempProbe™ Device EUDAMEDFDA UDI
- Generic Name
- Patient monitoring system module, temperature FDA UDI
- Device Name
- Temp Probe EUDAMEDTemperature probe FDA UDI
- Model / Reference
- DP40-0015-213 EUDAMEDFDA UDI
- Description
- Temperature probe FDA UDI
Identifiers
- Catalog Number
- CRYO-55-F FDA UDI
- Primary DI / UDI-DI
- 00810563020908 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200136PV EUDAMED
- Direct Marketing DI
- 00810563020908 EUDAMED
- 510(k) Number
- K153489 FDA UDI
- FDA Product Code
- GEH FDA UDI
- EMDN Code
- Z120102 CRYOSURGERY EQUIPMENT EUDAMED
- GMDN Term
- Patient monitoring system module, temperature FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Market of Registration
- Netherlands 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
MR Unsafe FDA UDI
TempProbe™ Device by Varian Medical Systems, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500200136PV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000007453
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED 9c8889c6-7f0f-4ad7-a801-1645f0588275 61 fields · synced Jul 13, 2026
- FDA UDI 4753f763-18f6-4eeb-9c24-988fdd1cb98c 35 fields · synced May 30, 2026