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iproven
EUDAMEDClass IIa (EU MDR)
Ref BBT-113AiModel DT-12Ref DTK-117YModel DT-K111B
Identity
- Trade Name
- iproven EUDAMED
- Device Name
- Digital Thermometer EUDAMED
- Model / Reference
- DT-12 EUDAMEDBBT-113Ai EUDAMEDDT-K111B EUDAMEDDTK-117Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931562702672 EUDAMED06931562702689 EUDAMED
- Basic UDI-DI
- B-06931562702672 EUDAMEDB-06931562702689 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iproven by Hangzhou Hua'an Medical & Health Instruments Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06931562702672 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013858
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED dcd401f1-ab8b-483d-a725-5f7f0e6b689a 61 fields · synced Oct 6, 2026
- EUDAMED 665e8204-0b76-4267-a574-7ac39618548b 61 fields · synced May 17, 2026