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Ecojekt

by H.S. Hospital Service SpA 15 variants

Ref E 2035Model ECOJEKT

Ecojekt (E2035) is a device classified as Class IIa in the EU and Class I in the US made by H.S. Hospital Service SpA, registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI B-08033003342633) and listed in FDA GUDID since 18 Dec 2019 (UDI-DI 08033003342633), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033003342633 Basic UDI-DI 08033003342633UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033003342633 UDI-DI Date18 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08033003342633 registered 21 Aug 2026 Active
  • FDA GUDID UDI-DI 08033003342633 listed 18 Dec 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033003342633
  2. Registered EUDAMED B-08033003342633

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  • Withdrawn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
ECOJEKT, E 2035, E2035
Primary DI / UDI-DI
08033003342633
Basic UDI-DI
B-08033003342633
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
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Needle Gauge — 20 Gauge
Length — 350 Millimeter

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.

Related devices

Category: Body aspiration needle, single-use

Similar devices in this category

Other devices filed under ASPIRATION FINE NEEDLES AND KITS.

Other devices from H.S. Hospital Service SpA

  • Trap Easy

    Class II

  • Ecojekt

    Class I

  • Bmn I Type

    Class II

  • Introducer Needle

    Class I

See all devices from H.S. Hospital Service SpA →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)