Skip to content

Apollo Balloon Dilatation Catheters

by BrosMed Medical Co., Ltd 76 variants

Ref 802-4518

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153742↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06958481411508 Basic UDI-DI 06958481411508UDI-DIDate27 Oct 2021RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK153742 Date8 Aug 2016IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Device Name
Apollo Balloon Dilatation Catheters
Model / Reference
802-4518
Primary DI / UDI-DI
06958481411508
Basic UDI-DI
B-06958481411508
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

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

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

Other devices from BrosMed Medical Co., Ltd.

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