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HandCut PM18114

by M.D.L. S.R.L. 2 variants

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

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08058341219188 UDI-DI Date4 Jan 2017ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDD EUDAMED Number— Date—StatusActive

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  • Withdrawn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
HandCut
Generic Name
Soft-tissue biopsy procedure kit, non-medicated
Model / Ref / Catalog
PM18114
Description
10 CS-DISPOSABLE NEEDLE 18G x114mm FOR SOFT TISSUE BIOPSY WITH MANUAL ACTION
Primary DI / UDI-DI
08058341219188
FDA Product Code
MJG
GMDN Term
Soft-tissue biopsy procedure kit, non-medicated
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 114 Millimeter
Needle Gauge — 18 Gauge

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
  • Premarket Exempt

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No