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SemiCut

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

Ref PD0PP1807

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-08058341217344 Basic UDI-DI 08058341217344UDI-DIDate11 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08058341217344 UDI-DI Date26 Apr 2021ListedStatusListed 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

    Sterility assurance may be compromised.

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  • Withdrawn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
SemiCut EUDAMED
SemiCut Coax. GUDID
Generic Name
End-cut biopsy gun handpiece/needle
Model / Ref / Catalog
PD0PP1807
Primary DI / UDI-DI
08058341217344
Basic UDI-DI
B-08058341217344
510(k) Number
FDA Product Code
FCG, KNW
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

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