Identity
- Trade Name
- TempaDOT R EUDAMEDTempaDOT FDA UDI
- Generic Name
- Colour-indication patient thermometer FDA UDI
- Device Name
- Clinical Thermometer EUDAMEDTempaDOT Plus C single use clinical Thermometer with Rectal Sheath FDA UDI
- Model / Reference
- 5502R EUDAMEDFDA UDI
- Description
- TempaDOT Plus C single use clinical Thermometer with Rectal Sheath FDA UDI
Identifiers
- Catalog Number
- TD Plus C FDA UDI
- Primary DI / UDI-DI
- 00016944301073 EUDAMEDFDA UDI
- Basic UDI-DI
- 016944TDNonsterileQP EUDAMED
- Unit of Use DI
- 10016944301070 EUDAMED
- FDA Product Code
- FQZ FDA UDI
- EMDN Code
- V03010199 THERMOMETERS - OTHER EUDAMED
- GMDN Term
- Colour-indication patient thermometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.2900 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.0022 Pound FDA UDI
TempaDOT R by Medical Indicators — Class I — 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 | 016944TDNonsterileQP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medical Indicators
- EUDAMED SRN
- US-MF-000018094
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 125da15e-a1a5-4581-95d4-0507ef5badc0 61 fields · synced May 30, 2026
- FDA UDI 73060ae8-fe27-458f-9b55-caad028fa3d2 36 fields · synced May 30, 2026