Identity
- Device Name
- Introducer sheaths EUDAMED
- Model / Reference
- BR-RA0716 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973245045591 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
Introducer sheaths 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 | 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 04ee856c-3401-4579-9954-e77c62a3c340 61 fields · synced Jun 20, 2026