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Atropos PTA Balloon Dilatation Catheter rev 01

by BrosMed Medical Co., Ltd.

Ref 819-050100-070

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number695848140015M4 Basic UDI-DI 06958481446241UDI-DIDate20 Dec 2023RegisteredStatusActive
European UnionCE/MDR EUDAMED Number695848140015M4 Basic UDI-DI 06958481446241UDI-DIDate20 Dec 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06958481446241 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 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR 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
819-050100-070 EUDAMED
rev 01 GUDID
819-050100-070U GUDID
Primary DI / UDI-DI
06958481446241
Basic UDI-DI
695848140015M4, B-06958481446241
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
819-050100-070
GUDID
rev 01
Device ClassEUDAMED
Class IIa
GUDID
Class II

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