Identity
- Device Name
- Bracket EUDAMED
- Model / Reference
- NA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251934201100 EUDAMED
- Basic UDI-DI
- 42519342TR003EW EUDAMED
- EMDN Code
- C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular guidewire introduction sleeve
Bracket by Shenzhen Keborui Electronics Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 42519342TR003EW | 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 066ace05-c5a2-4f20-81a1-af91f2daa13c 61 fields · synced Jul 11, 2026