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Themy

by M.D.L. S.r.l. 20 variants

Ref TY1820

Themy (TY1820) is a device classified as Class IIa in the EU and Class II in the US made by M.D.L. S.R.L., registered in EUDAMED on 20 Feb 2026 (Basic UDI-DI B-08052440100019), cleared under FDA 510(k) K160316 on 27 Oct 2016 and listed in FDA GUDID since 4 Jan 2017 (UDI-DI 08052440100019), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160316

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08052440100019 Basic UDI-DI 08052440100019UDI-DIDate20 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052440100019 UDI-DI Date4 Jan 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160316 Date27 Oct 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08052440100019 registered 20 Feb 2026 Active
  • FDA 510(k) K160316 decided 27 Oct 2016 Active
  • FDA GUDID UDI-DI 08052440100019 listed 4 Jan 2017 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K160316
  2. Listed FDA GUDID 08052440100019
  3. Recall initiated FDA recalls Z-2492-2021
  4. Registered EUDAMED B-08052440100019

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
End-cut biopsy gun handpiece/needle
Model / Ref / Catalog
TY1820
Description
5 CS- THEMY AUTOMATIC NEEDLE 18Gx200mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm
Primary DI / UDI-DI
08052440100019
Basic UDI-DI
B-08052440100019
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 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 — 18 Gauge
Length — 200 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II 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
Other properties (20, all answered No)