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Polux Pro

by BrosMed Medical Co., Ltd

Ref P14-040015-200, 818-035100-150, P14-060030-120, 818-045060-070, P14-030080-200, P14-050025-120, P14-025030-070, P14-040220-090, P14-010025-090, 818-050005-150, P14-035020-150, P14-060060-120, P14-045040-090, 818-020030-150, 818-015150-150, P14-045020-200, P14-035300-150, P14-050220-120, 818-045010-070, P14-015025-150, P14-030100-200, P14-010030-120, P14-050060-200, 818-045080-090, P14-045100-090, P14-060040-200, 818-060040-150, P14-055200-090, P14-040025-120, P14-060060-200, P14-012040-150, P14-012020-200, 818-015020-090, P14-055150-200, P14-025025-150, P14-060020-200, P14-015100-120, P14-035020-200, P14-010015-120, 818-055020-150, P14-055025-090, P14-050100-070, P14-025040-150, P14-025020-120, P14-055250-120, 818-055120-150, P14-055030-150, P14-020030-070, P14-040150-120, P14-040030-090, P14-045100-070

Active European Union

CE MDR CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number695848140063MF Basic UDI-DI Date19 Aug 2024RegisteredStatusActive
European UnionCE/MDD Number695848140063MF Basic UDI-DI Date19 Aug 2024RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Trade Name
Polux Pro
Polux
Device Name
Polux Pro / Parafleet SC 014 PTA Balloon Dilatation Catheter
Polux PTA Balloon Dilatation Catheter
Model / Reference
P14-040015-200, 818-035100-150, P14-060030-120, 818-045060-070, P14-030080-200, P14-050025-120, P14-025030-070, P14-040220-090, P14-010025-090, 818-050005-150, P14-035020-150, P14-060060-120, P14-045040-090, 818-020030-150, 818-015150-150, P14-045020-200, P14-035300-150, P14-050220-120, 818-045010-070, P14-015025-150, P14-030100-200, P14-010030-120, P14-050060-200, 818-045080-090, P14-045100-090, P14-060040-200, 818-060040-150, P14-055200-090, P14-040025-120, P14-060060-200, P14-012040-150, P14-012020-200, 818-015020-090, P14-055150-200, P14-025025-150, P14-060020-200, P14-015100-120, P14-035020-200, P14-010015-120, 818-055020-150, P14-055025-090, P14-050100-070, P14-025040-150, P14-025020-120, P14-055250-120, 818-055120-150, P14-055030-150, P14-020030-070, P14-040150-120, P14-040030-090, P14-045100-070
Primary DI / UDI-DI
06958481449952, 06958481442571, 06958481443660, 06958481443196, 06958481449730, 06958481442779, 06958481414790, 06958481439304, 06958481422009, 06958481445251, 06958481445626, 06958481443684, 06958481439373, 06958481442175, 06958481442113, 06958481450668, 06958481445749, 06958481442861, 06958481443141, 06958481443905, 06958481449747, 06958481439939, 06958481450842, 06958481444209, 06958481439403, 06958481451672, 06958481445541, 06958481439717, 06958481441895, 06958481451689, 06958481443875, 06958481447965, 06958481441048, 06958481451580, 06958481444759, 06958481451641, 06958481440676, 06958481449822, 06958481439908, 06958481445404, 06958481439632, 06958481416824, 06958481444773, 06958481440867, 06958481443615, 06958481445466, 06958481446920, 06958481413960, 06958481441963, 06958481439229, 06958481415995
Basic UDI-DI
695848140063MF, B-06958481442571, B-06958481443196, 695848140011LU, B-06958481442175, B-06958481444209, B-06958481441048, B-06958481445404, B-06958481445466
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

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

Related devices

Category: Peripheral angioplasty balloon catheter, basic

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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