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CytoCut

by M.D.L. S.r.l. 14 variants

Ref PB1825

CytoCut (PB1825) 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 6 Feb 2026 (Basic UDI-DI B-08032986351953) and listed in FDA GUDID since 4 Jan 2017 (UDI-DI 08032986351953), 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-08032986351953 Basic UDI-DI 08032986351953UDI-DIDate6 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08032986351953 UDI-DI Date4 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08032986351953 registered 6 Feb 2026 Active
  • FDA GUDID UDI-DI 08032986351953 listed 4 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08032986351953
  2. Registered EUDAMED B-08032986351953

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  • Withdrawn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
Body aspiration needle, single-use
Model / Ref / Catalog
PB1825
Description
10 CS - DISPOSABLE CHIBA NEEDLE 18G x 250 mm FOR ASPIRATED CYTO-HISTOLOGICAL BIOPSY
Primary DI / UDI-DI
08032986351953
Basic UDI-DI
B-08032986351953
FDA product code
GAA
EMDN code
A01020102 Aspiration fine needles and kits
GMDN term
Body aspiration needle, single-use
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
Length — 250 Millimeter
Needle Gauge — 18 Gauge

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

Related devices

Category: Diskectomy system, percutaneous, automatic

Similar devices in this category

Other devices filed under ASPIRATION FINE 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)