Identity
- Device Name
- Introducer sheaths EUDAMED
- Model / Reference
- BR-FA0911 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973245045690 EUDAMED
- Basic UDI-DI
- 697324504IS0009AG EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED 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
Category: Vascular catheter introduction set, nonimplantable
Introducer sheaths by Brun Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Vascular catheter introduction set, nonimplantable.
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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 | 697324504IS0009AG | 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 3d8ce5d1-879a-4f93-9398-272d9e9c08af 61 fields · synced Jun 18, 2026