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Cook G05040

by Cook Incorporated

Ref DCHN-18-10.0-U

Cook G05040 (DCHN-18-10.0-U) is a device classified as Class IIa in the EU and Class I in the US made by Cook Incorporated, registered in EUDAMED on 23 Feb 2026 (Basic UDI-DI B-00827002050402) and listed in FDA GUDID since 2 Oct 2020 (UDI-DI 00827002050402), 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-00827002050402 Basic UDI-DI 00827002050402UDI-DIDate23 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002050402 UDI-DI Date2 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002050402 registered 23 Feb 2026 Active
  • FDA GUDID UDI-DI 00827002050402 listed 2 Oct 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00827002050402
  2. Registered EUDAMED B-00827002050402

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  • Withdrawn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
Cook
Generic name
Body aspiration needle, single-use
Model / Ref / Catalog
DCHN-18-10.0-U, G05040
Primary DI / UDI-DI
00827002050402
Basic UDI-DI
B-00827002050402
FDA product code
MJG
EMDN code
A010299 Biopsy needles and kits - other
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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DCHN-18-10.0-U
GUDID
G05040
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 BIOPSY NEEDLES AND KITS - OTHER.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)