Identity
- Device Name
- Guide Wires EUDAMED
- Model / Reference
- BR-NGW021-45J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973245043238 EUDAMED
- Basic UDI-DI
- 697324504GW0010AK EUDAMED
- EMDN Code
- C04020202 PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Guide Wires by Brun Medical Co., Ltd. — Class IIa — 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 | 697324504GW0010AK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Brun Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009738
- Authorised Representative
- Cnovate Medical B.V. NL-AR-000039205
Sources (1)
- EUDAMED 75aef736-4b7d-4f71-b0e9-b5ff45d2a67f 61 fields · synced Jun 18, 2026