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Palium Needle

by M.D.L. S.r.l. 11 variants

Ref MGK11210

Palium Needle (MGK11210) is a device classified as Class IIa in the EU and Class I in the US made by M.D.L. S.R.L., registered in EUDAMED on 4 Feb 2026 (Basic UDI-DI B-08058341210413) and listed in FDA GUDID since 5 Jan 2017 (UDI-DI 08058341210413), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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-08058341210413 Basic UDI-DI 08058341210413UDI-DIDate4 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08058341210413 UDI-DI Date5 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08058341210413 registered 4 Feb 2026 Active
  • FDA GUDID UDI-DI 08058341210413 listed 5 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08058341210413
  2. Registered EUDAMED B-08058341210413

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  • Withdrawn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
Palium Needle EUDAMED
PaliumNeedle GUDID
Generic name
End-cut biopsy gun needle
Model / Ref / Catalog
MGK11210
Description
10 CS-DISP.NEEDLE 12GX100mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITH BARD AUTOM.MAGNUM GUN/PALIUM GUN
Primary DI / UDI-DI
08058341210413
Basic UDI-DI
B-08058341210413
FDA product code
MJG
EMDN code
A0102010101 Shearing biopsy needles
GMDN term
End-cut biopsy gun needle
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 100 Millimeter
Needle Gauge — 12 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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.

Manufacturer details

EUDAMED SRN
IT-MF-000011599

Similar devices in this category

Other devices filed under NEEDLES.

Other devices from M.D.L. S.R.L.

See all devices from M.D.L. S.R.L. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)