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Needle

by Argon Medical Devices, Inc. 14 variants

Ref 195311

Needle (195311) is a device classified as Class IIa in the EU and Class I in the US made by Argon Medical Devices, Inc., registered in EUDAMED on 24 Apr 2026 (Basic UDI-DI B-10886333208378) and listed in FDA GUDID since 28 Jun 2022 (UDI-DI 10886333208378), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10886333208378 Basic UDI-DI 10886333208378UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10886333208378 UDI-DI Date28 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10886333208378 registered 24 Apr 2026 Active
  • FDA GUDID UDI-DI 10886333208378 listed 28 Jun 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10886333208378
  2. Registered EUDAMED B-10886333208378

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  • Withdrawn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
Needle EUDAMED
Arterial Needle GUDID
Generic name
Vascular catheter introduction needle
Device name
AMC/3 Arterial Needle
Model / Ref / Catalog
195311
Description
AMC/3 Arterial Needle – 21ga x 1” (2.5cm)
Primary DI / UDI-DI
10886333208378 EUDAMED
00886333208371 GUDID
Basic UDI-DI
B-10886333208378
FDA product code
GDF
EMDN code
C0504, C058099
GMDN term
Vascular catheter introduction needle
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10886333208378
GUDID
00886333208371
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10886333208378; FDA GUDID lists 00886333208371), so their flags are not compared. 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
US-MF-000002324
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS - ACCESSORIES.

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

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