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Magnum MN1213

by Bard Peripheral Vascular

Part of a family of 22 devices: see the family page

Ref MN1213

Magnum MN1213 is a device classified as Class IIa in the EU and Class II in the US made by Bard Peripheral Vascular, registered in EUDAMED on 25 Aug 2026 (Basic UDI-DI 0801741KSIXLFKD4F) and listed in FDA GUDID since 6 Sep 2016 (UDI-DI 00801741084218), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741KSIXLFKD4F Basic UDI-DI 00801741084218UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741084218 UDI-DI Date6 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0801741KSIXLFKD4F registered 25 Aug 2026 Active
  • FDA GUDID UDI-DI 00801741084218 listed 6 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00801741084218
  2. Registered EUDAMED 0801741KSIXLFKD4F

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  • Withdrawn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
Magnum
Generic name
Side-notch biopsy gun needle
Device name
Magnum™ Disposable Core Biopsy Needle
Model / Ref / Catalog
MN1213
Primary DI / UDI-DI
00801741084218
Basic UDI-DI
0801741KSIXLFKD4F
FDA product code
FCG
EMDN code
A0102010101 Shearing biopsy needles
GMDN term
Side-notch biopsy gun needle
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 12 Gauge
Length — 13 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Side-notch biopsy gun needle

Similar devices in this category

Other devices filed under SHEARING BIOPSY NEEDLES.

Other devices from Bard Peripheral Vascular

See all devices from Bard Peripheral Vascular →

Properties

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