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Introducer Sheath Sets

by BrosMed Medical 274 variants

Ref 4F16M25S

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 Number695848140077MS Basic UDI-DI 06942265599414UDI-DIDate12 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
4F16M25S
Primary DI / UDI-DI
06942265599414
Basic UDI-DI
695848140077MS
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
Medical Purpose
Introducer Sheath Sets (including Introducer Sheaths, Dilators, Guide Wires, Introducer Needles, Scalpels, and Syringes)

Manufacturer details

EUDAMED SRN
CN-PR-000048143

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from BrosMed Medical Co., Ltd.

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Properties

  • Sterile