Identity
- Trade Name
- ThermoMax Digital Baby EUDAMEDDr. Max ThermoMax Digital Baby EUDAMED
- Device Name
- Digital Clinical Thermometer EUDAMED
- Model / Reference
- FDTH-V0-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595566423117 EUDAMED
- Basic UDI-DI
- 697038963FDTHV0RA EUDAMED
- Direct Marketing DI
- 08595566423117 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 Baby 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 | 697038963FDTHV0RA | 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 f92b6322-eea6-4d32-9a26-09c895a6f4d9 61 fields · synced Jul 10, 2026
- EUDAMED 3d52bb36-b04a-4e38-8e96-1db55106c38a 61 fields · synced Jul 10, 2026