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MDCut P

by M.D.L. S.r.l. 5 variants

Ref MGP1412

MDCut P (MGP1412) 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 5 Feb 2026 (Basic UDI-DI B-08052440109876) and listed in FDA GUDID since 5 Jan 2017 (UDI-DI 08052440109876), 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-08052440109876 Basic UDI-DI 08052440109876UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052440109876 UDI-DI Date5 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08052440109876 registered 5 Feb 2026 Active
  • FDA GUDID UDI-DI 08052440109876 listed 5 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08052440109876
  2. Registered EUDAMED B-08052440109876

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  • Withdrawn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
MDCut P EUDAMED
FastCutP GUDID
Generic name
End-cut biopsy gun needle
Model / Ref / Catalog
MGP1412
Description
10 CS - DISPOSABLE NEEDLE 14Gx120mm FOR SOFT TISSUE BIOPSY COMPATIBLE AUTOMATIC PROMAG® GUN
Primary DI / UDI-DI
08052440109876
Basic UDI-DI
B-08052440109876
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
Needle Gauge — 14 Gauge
Length — 120 Millimeter

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 SHEARING BIOPSY NEEDLES AND KITS.

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
Other properties (19, all answered No)