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Biopsy Needle

by Argon Medical Devices, Inc. 69 variants

Ref MFN2206

Biopsy Needle (MFN2206) is a device classified as Class IIa in the EU and Class II in the US made by Argon Medical Devices, Inc., registered in EUDAMED on 27 Apr 2026 (Basic UDI-DI B-20886333002607), cleared under FDA 510(k) K980122 on 30 Jan 1998 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 20886333002607), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K980122

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-20886333002607 Basic UDI-DI 20886333002607UDI-DIDate27 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20886333002607 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK980122 Date30 Jan 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20886333002607 registered 27 Apr 2026 Active
  • FDA 510(k) K980122 decided 30 Jan 1998 Active
  • FDA GUDID UDI-DI 20886333002607 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K980122
  2. Listed FDA GUDID 20886333002607
  3. Registered EUDAMED B-20886333002607

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  • Withdrawn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

Trade name
Biopsy Needle EUDAMED
Franseen Biopsy Needle GUDID
Generic name
Soft-tissue biopsy needle, single-use
Model / Ref / Catalog
MFN2206
Primary DI / UDI-DI
20886333002607 EUDAMED
00886333002603 GUDID
Basic UDI-DI
B-20886333002607
510(k) Number
FDA product code
KNW
EMDN code
A01020102 Aspiration fine needles and kits
GMDN term
Soft-tissue biopsy needle, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
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
20886333002607
GUDID
00886333002603
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 20886333002607; FDA GUDID lists 00886333002603), so their flags are not compared. 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
US-MF-000002324
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Diskectomy system, percutaneous, automatic

Similar devices in this category

Other devices filed under ASPIRATION FINE NEEDLES AND KITS.

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)