Identity
- Trade Name
- TempaDOT, C Sterile bulk EUDAMED
- Device Name
- Clinical Thermometer EUDAMED
- Model / Reference
- 5538 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20016944301091 EUDAMED
- Basic UDI-DI
- 016944TDsterileEC EUDAMED
- Unit of Use DI
- 10016944301087 EUDAMED
- EMDN Code
- V03010199 THERMOMETERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
TempaDOT, C Sterile bulk by Medical Indicators — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 016944TDsterileEC | Class I | Active |
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Manufacturer
- Manufacturer
- Medical Indicators
- EUDAMED SRN
- US-MF-000018094
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED c4bf7d12-4a85-4770-be93-a40f59f1a5cb 61 fields · synced Jun 19, 2026