Introducer Sheath Sets

by BrosMed Medical Co., Ltd 274 variants

Ref BM-FA0611A

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	NumberB-06958481494761 Basic UDI-DI 06958481494761UDI-DI	Date22 Nov 2021Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference: BM-FA0611A

Primary DI / UDI-DI: 06958481494761
Basic UDI-DI: B-06958481494761, 695848140077MS
EMDN Code: C0504, C0502

Device Class: Class IIa
EU market of registration: Netherlands
Medical Purpose: Introducer Sheath Sets (including Introducer Sheaths, Dilators, Guide Wires, Introducer Needles, Scalpels, and Syringes)

Manufacturer details

EUDAMED SRN: CN-MF-000007501
Authorised representative: Brosmed Medical B.V. NL-AR-000002616

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See all devices from BrosMed Medical Co., Ltd. →

Properties

Sterile

Other properties (10)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No