Skip to content

Breast Localization Needles BLN2005

by Argon Medical Devices, Inc.

Ref BLN2005

Breast Localization Needles BLN2005 is a device classified as Class IIa in the EU and Class I in the US made by Argon Medical Devices, Inc., registered in EUDAMED on 8 May 2026 (Basic UDI-DI B-20886333007503) and listed in FDA GUDID since 30 Jun 2022 (UDI-DI 20886333007503), active as of 22 Oct 2026.

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

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20886333007503 Basic UDI-DI 20886333007503UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20886333007503 UDI-DI Date30 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-20886333007503 registered 8 May 2026 Active
  • FDA GUDID UDI-DI 20886333007503 listed 30 Jun 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 20886333007503
  2. Registered EUDAMED B-20886333007503

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Accura BLN EUDAMED
Breast Localization Needles GUDID
Generic name
Radiological image marker, implantable
Model / Ref / Catalog
BLN2005
Primary DI / UDI-DI
20886333007503 EUDAMED
00886333007509 GUDID
Basic UDI-DI
B-20886333007503
FDA product code
GAA
EMDN code
A019012 Breast nodules and other structures localisation needles and systems
GMDN term
Radiological image marker, implantable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20886333007503
GUDID
00886333007509
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 20886333007503; FDA GUDID lists 00886333007509), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radiological image marker, implantable

Similar devices in this category

Other devices filed under BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS.

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)