Identity
- Trade Name
- Digital Clinical Thermometer EUDAMEDFamidoc FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Digital Clinical Thermometer EUDAMED
- Model / Reference
- FDTH-V0-8 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970389632083 EUDAMEDFDA UDI
- Basic UDI-DI
- 697038963FDTHV1RC EUDAMED
- Direct Marketing DI
- 06970389632083 EUDAMED
- 510(k) Number
- K072641 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
- GMDN Term
- Intermittent electronic patient thermometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Digital Clinical Thermometer by Famidoc Technology Co., Ltd. — Class IIa — 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 | 697038963FDTHV1RC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 7ef66a2e-fe05-4763-97b0-7049a29013fc 61 fields · synced Jun 19, 2026
- FDA UDI 63f12ebb-1ecc-4c45-87b7-90453c9288d8 33 fields · synced May 30, 2026