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Digital Clinical Thermometer
EUDAMEDClass IIa (EU MDR)
Ref FDTH-V0-13Ref FDTH-V0-4Ref FDTH-V0-12Ref FDTH-V0-1Ref FDTH-V0-11
Identity
- Trade Name
- Digital Clinical Thermometer EUDAMED
- Device Name
- Digital Clinical Thermometer EUDAMED
- Model / Reference
- FDTH-V0-13 EUDAMEDFDTH-V0-4 EUDAMEDFDTH-V0-12 EUDAMEDFDTH-V0-1 EUDAMEDFDTH-V0-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970389631307 EUDAMED06970389632045 EUDAMED06970389632120 EUDAMED06970389632014 EUDAMED06970389632588 EUDAMED
- Basic UDI-DI
- 697038963FDTHV1RC EUDAMED697038963FDTHV0RA EUDAMED
- Direct Marketing DI
- 06970389631307 EUDAMED06970389632045 EUDAMED06970389632120 EUDAMED06970389632014 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDMalta EUDAMEDNetherlands EUDAMEDGermany 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
Digital Clinical Thermometer 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 (5)
- EUDAMED b0216025-b179-4f58-9d25-3aeb3872c7b0 61 fields · synced Jul 30, 2026
- EUDAMED 6e09c823-5d63-4285-b6c3-8d87fcce10b7 61 fields · synced May 18, 2026
- EUDAMED 0f8177ea-34a5-4ffa-901a-e8795aea8aa8 61 fields · synced May 18, 2026
- EUDAMED b452ba25-1837-4f55-9d81-70cb77ea1b40 61 fields · synced May 19, 2026
- EUDAMED ed0f7089-c957-4988-bb4d-12488ee1c8a6 61 fields · synced Jul 12, 2026