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BIOSYNEX Thermometre Souple et Rapide 10 secondes Universal
EUDAMEDClass IIa (EU MDR)
Ref 860986Model DT-K111B
Identity
- Trade Name
- BIOSYNEX Thermometre Souple et Rapide 10 secondes Universal EUDAMED
- Device Name
- Digital Thermometer EUDAMED
- Model / Reference
- DT-K111B EUDAMED860986 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931562703662 EUDAMED
- Basic UDI-DI
- B-06931562703662 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 Thermometre Souple et Rapide 10 secondes Universal by Hangzhou Hua'an Medical & Health Instruments Co., Ltd. — Class IIa — MDD — listed in EUDAMED
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-06931562703662 | 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 (1)
- EUDAMED 83b811ce-20b8-469c-ae7d-c37b4fda49ad 61 fields · synced Oct 6, 2026