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Atropos PTA Balloon Dilatation Catheter

by BrosMed Medical Co., Ltd 82 variants

Ref 819-090150-090

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Overview

The Atropos PTA Balloon Dilatation Catheter is a Class IIa medical device used for the treatment of certain conditions. It is designed to provide accurate and effective balloon dilatation, allowing for the administration of medications and minimization of complications.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-06958481447620 Basic UDI-DI 06958481447620UDI-DIDate12 Nov 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-06958481447620 Basic UDI-DI 06958481447620UDI-DIDate12 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06958481447620 UDI-DI Date28 Nov 2016ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Atropos EUDAMED
Atropos PTA Balloon Dilatation Catheter GUDID
Generic Name
Peripheral angioplasty balloon catheter, basic
Device Name
Atropos / Xpansion AVF PTA Balloon Dilatation Catheter
Model / Ref / Catalog
819-090150-090 EUDAMED
rev 01 GUDID
819-090150-090U GUDID
Primary DI / UDI-DI
06958481447620
Basic UDI-DI
B-06958481447620, 695848140015M4
510(k) Number
FDA Product Code
LIT
EMDN Code
C010402020101 PTA balloon dilatation catheters
GMDN Term
Peripheral angioplasty balloon catheter, basic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1250
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
819-090150-090
GUDID
rev 01
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Other devices from BrosMed Medical Co., Ltd.

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

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No