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Armada B2100-060

by Abbott Vascular

Ref B2100-060

Armada B2100-060 is a device classified as Class IIa in the EU and Class II in the US made by Abbott Vascular, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 8717648PDC0004TZ) and listed in FDA GUDID since 15 Jan 2016 (UDI-DI 08717648155529), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8717648PDC0004TZ Basic UDI-DI 08717648155529UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717648155529 UDI-DI Date15 Jan 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8717648PDC0004TZ registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 08717648155529 listed 15 Jan 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08717648155529
  2. Registered EUDAMED 8717648PDC0004TZ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Armada™ 35 PTA Catheter EUDAMED
Armada GUDID
Generic name
Peripheral angioplasty balloon catheter, basic
Device name
Peripheral Dilatation Catheter, Armada 35/35LL
Model / Ref / Catalog
B2100-060
Primary DI / UDI-DI
08717648155529
Basic UDI-DI
8717648PDC0004TZ
FDA product code
DQY, 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 registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Peripheral angioplasty balloon catheter, basic

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)