Identity
- Trade Name
- LIFESYNE VITALS EUDAMED
- Device Name
- Digital Thermometer EUDAMED
- Model / Reference
- DT-K111B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16931562703478 EUDAMED
- Basic UDI-DI
- B-16931562703478 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lifesyne Vitals 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-16931562703478 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000013858
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 29933528-bc4a-466b-8cec-4f178f67ac9c 61 fields · synced Oct 6, 2026