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SemiCut

by M.D.L. S.r.l. 24 variants

Ref PD0PP1610

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08052440106059 Basic UDI-DI 08052440106059UDI-DIDate11 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052440106059 UDI-DI Date4 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-2492-2021 FDA Class II initiated 5 Aug 2021 on shared 510(k) K160316

    Sterility assurance may be compromised.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

Generic Name
End-cut biopsy gun handpiece/needle
Model / Ref / Catalog
PD0PP1610
Description
10 CS-SEMIAUTOMATIC NEEDLE 16G X 100MM WITHOUT REMOVABLE LUER, WITH INTRODUCER
Primary DI / UDI-DI
08052440106059
Basic UDI-DI
B-08052440106059
510(k) Number
FDA Product Code
FCG
EMDN Code
A0102010101 Shearing biopsy needles
GMDN Term
End-cut biopsy gun handpiece/needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 100 Millimeter
Needle Gauge — 16 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000011599

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

See all devices from M.D.L. S.R.L. →

Properties

  • Sterile
  • Single Use
  • Prescription Use

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No