Atropos PTA Balloon Dilatation Catheter

EUDAMED

Class IIa (EU MDR)

Ref 819-050030-040

by BrosMed Medical Co., Ltd

Identity

Device Name: Atropos PTA Balloon Dilatation Catheter EUDAMED
Model / Reference: 819-050030-040 EUDAMED

Identifiers

Primary DI / UDI-DI: 06958481460100 EUDAMED
Basic UDI-DI: B-06958481460100 EUDAMED
EMDN Code: C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Netherlands EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Peripheral angioplasty balloon catheter, basic

Atropos PTA Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

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Pacific™ Plus — MEDTRONIC, INC. · Class II
Metacross OTW — KANEKA Corporation · Class IIa
Armada — Abbott Vascular · Class II
RapidCross — Covidien LP · Class II

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06958481460100	Class IIa	Active

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Manufacturer

Manufacturer: BrosMed Medical Co., Ltd
EUDAMED SRN: CN-MF-000007501
Authorised Representative: Brosmed Medical B.V. NL-AR-000002616

Sources (1)

EUDAMED 6e266583-6d48-408a-b117-9d5ce028e83b 61 fields · synced May 23, 2026