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Biosynex
EUDAMEDClass IIa (EU MDR)
Ref 455817Model DT-111BRef 858928Model DT-K111BRef DT-111GRef 858737Model DT-01A
Identity
- Trade Name
- BIOSYNEX EUDAMED
- Device Name
- Digital Thermometer EUDAMED
- Model / Reference
- DT-111B EUDAMED455817 EUDAMEDDT-K111B EUDAMED858928 EUDAMEDDT-111G EUDAMEDDT-01A EUDAMED858737 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931562702238 EUDAMED06931562702221 EUDAMED06931562702900 EUDAMED06931562702214 EUDAMED
- Basic UDI-DI
- B-06931562702238 EUDAMEDB-06931562702221 EUDAMEDB-06931562702900 EUDAMEDB-06931562702214 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Biosynex 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-06931562702238 | 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 (4)
- EUDAMED 8c951dce-dd1f-4968-875e-28d9759292da 61 fields · synced Oct 6, 2026
- EUDAMED 65cb5e8d-976b-4d40-9438-330b96e407bd 61 fields · synced May 17, 2026
- EUDAMED 3baab967-fbc5-42cc-9e32-a518ab693f1a 61 fields · synced May 18, 2026
- EUDAMED c52b7638-f53a-4215-a148-487b836a7c10 61 fields · synced May 19, 2026