Identity
- Trade Name
- ThermoMax Digital Comfort EUDAMEDDr. Max ThermoMax Digital Comfort EUDAMED
- Device Name
- Digital Clinical Thermometer EUDAMED
- Model / Reference
- FDTH-V0-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595566423049 EUDAMED
- Basic UDI-DI
- 697038963FDTHV1RC EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
ThermoMax Digital Comfort by Famidoc Technology Co., Ltd. — Class IIa — 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 | 697038963FDTHV1RC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Famidoc Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016603
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED ae2ac780-adc2-45cf-9251-3dcffc3b0a09 61 fields · synced Jul 12, 2026
- EUDAMED 80a9d89a-1ecd-412b-b419-938be59671d2 61 fields · synced Jul 12, 2026