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Senti2
EUDAMEDClass IIa (EU MDR)
Ref 0DT008+1AC007Model DT007, DT008, DT113, DT116, DT117, DT119
Identity
- Trade Name
- Senti2 EUDAMED
- Device Name
- Digital Thermometer EUDAMED
- Model / Reference
- DT007, DT008, DT113, DT116, DT117, DT119 EUDAMED0DT008+1AC007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947656117352 EUDAMED
- Basic UDI-DI
- 69476561DTXXX4R EUDAMED
- Direct Marketing DI
- 06947656117352 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Senti2 by Guangzhou Berrcom Medical Device 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 | 69476561DTXXX4R | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Berrcom Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000013852
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 621c403a-9428-46c7-9ba6-fd26be0d568f 61 fields · synced Jun 19, 2026