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Introducer sheaths

by Brun Medical Co., Ltd. 16 variants

Ref BR-RA0607, BR-FA0611, BR-RA0711, BR-RA0707, BR-RA0516, BR-RA0416, BR-FA0711, BR-RA0423, BR-RA0507, BR-RA0723, BR-FA0623, BR-FA1223, BR-RA0616, BR-FA0823, BR-RA0411, BR-FA0723, BR-FA0409

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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697324504IS0009AG Basic UDI-DI Date12 May 2025RegisteredStatusActive

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

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Introducer sheaths
Model / Reference
BR-RA0607, BR-FA0611, BR-RA0711, BR-RA0707, BR-RA0516, BR-RA0416, BR-FA0711, BR-RA0423, BR-RA0507, BR-RA0723, BR-FA0623, BR-FA1223, BR-RA0616, BR-FA0823, BR-RA0411, BR-FA0723, BR-FA0409
Primary DI / UDI-DI
06973245045508, 06973245045669, 06973245045553, 06973245045515, 06973245045577, 06973245045560, 06973245045676, 06973245045607, 06973245045492, 06973245045638, 06973245045737, 06973245045775, 06973245045584, 06973245045751, 06973245045522, 06973245045744, 06973245045645
Basic UDI-DI
697324504IS0009AG
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000009738
Authorised representative
Cnovate Medical B.V. NL-AR-000039205

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Brun Medical Co., Ltd.

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

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No