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Temperature Probe
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref TP2AS22R01Ref 01.15.040254
Identity
- Trade Name
- Temperature Probe EUDAMEDFDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Device Name
- Temperature Probe EUDAMED
- Model / Reference
- TP2AS22R01 EUDAMED01.15.040254 EUDAMEDrectal/oral ,neonatal/Infant,3m,reusable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413847309 EUDAMED06944413804760 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138TP24C EUDAMED69444138TPG5 EUDAMED
- Direct Marketing DI
- 06944413804760 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMEDV03010299 BODY TEMPERATURE MONITORING PROBES - OTHER EUDAMED
- GMDN Term
- General-purpose patient temperature probe, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Germany 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
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Temperature Probe by Edan Instruments, Inc. — Class IIb — 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 | 69444138TP24C | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 97250595-d971-40ec-ad49-86ec0f9ff5ee 61 fields · synced Jul 22, 2026
- FDA UDI 6c679f56-7476-4564-acdf-16c491f8921f 32 fields · synced May 30, 2026
- EUDAMED 04ba8ae5-8c3e-49dc-ba26-3ca865daf837 61 fields · synced Jul 22, 2026