Identity
- Trade Name
- TraxIt Bulk Packed EUDAMED
- Device Name
- Clinical Thermometer EUDAMED
- Model / Reference
- 2313-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60016944701080 EUDAMED
- Basic UDI-DI
- 016944TXTXR EUDAMED
- Unit of Use DI
- 10016944701085 EUDAMED
- EMDN Code
- V03010199 THERMOMETERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
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
TraxIt Bulk Packed 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 | 016944TXTXR | 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 88fbe460-4429-411b-b063-9b6494cd6330 61 fields · synced Jul 13, 2026