Identity
- Device Name
- Simulator EUDAMED
- Model / Reference
- NA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251934203449 EUDAMED
- Basic UDI-DI
- 42519342TR001ES EUDAMED
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Simulator by Shenzhen Keborui Electronics Co., Ltd — Class I — 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 | 42519342TR001ES | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Keborui Electronics Co., Ltd
- EUDAMED SRN
- CN-MF-000007718
- Authorised Representative
- Tri Rad Medical GmbH DE-AR-000006744
Sources (1)
- EUDAMED 26fab9eb-1dd3-4723-bf60-52283802de22 61 fields · synced Jul 18, 2026