Identity
- Trade Name
- Introducer Sheath Sets EUDAMED
- Device Name
- Introducer Sheath Sets EUDAMED
- Model / Reference
- BM-FA0419B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958481494686 EUDAMED
- Basic UDI-DI
- B-06958481494686 EUDAMED695848140077MS EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMEDC0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Medical Purpose
- Introducer Sheath Sets (including Introducer Sheaths, Dilators, Guide Wires, Introducer Needles, Scalpels, and Syringes) EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Interventional radiology percutaneous-access kit, single-use
Introducer Sheath Sets by BrosMed Medical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Interventional radiology percutaneous-access kit, single-use.
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- EXTesia — Curatia Medical Limited · Class IIa
- Shun Guider — Shunmei Medical Co.,Ltd · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06958481494686 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06958481494686 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BrosMed Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000007501
- Authorised Representative
- Brosmed Medical B.V. NL-AR-000002616
Sources (2)
- EUDAMED 8690fc8d-1480-49a2-abf2-03da43828786 61 fields · synced Jun 19, 2026
- EUDAMED b7e16f66-bb22-4527-858d-47ebbda685bd 61 fields · synced Jun 19, 2026