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Achilles

by BrosMed Medical Co., Ltd 12 variants

Ref 804-030020-040

Active European Union

CE MDR CE MDD

Valid until

No date given

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 27 Oct 2026. What this means

Regulatory status

as of registry sync 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number695848140014M2 Basic UDI-DI 06958481458015UDI-DIDate20 Dec 2023RegisteredStatusActive
European UnionCE/MDR Number695848140014M2 Basic UDI-DI 06958481458015UDI-DIDate20 Dec 2023RegisteredStatusActive

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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Model / reference
804-030020-040
Primary DI / UDI-DI
06958481458015
Basic UDI-DI
695848140014M2, B-06958481458015
EMDN code
C010402020101 PTA balloon dilatation catheters
Device class
Class IIa
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

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

Overview

AI-generated summary, 27 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Achilles PTA Balloon Dilatation Catheter is a balloon dilatation catheter. This device is listed under an EU MDD registration and an EU MDR registration.

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Other devices from BrosMed Medical Co., Ltd.

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

Properties

  • Supplied sterile

Other properties (13)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No