Skip to content

Max-Core MC1810

by Bard Peripheral Vascular

Part of a family of 11 devices: see the family page

Ref MC1810

Max-Core MC1810 is a device classified as Class IIa in the EU and Class II in the US made by Bard Peripheral Vascular, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 0801741TWDGVBDC4V) and listed in FDA GUDID since 6 Sep 2016 (UDI-DI 00801741084461), active as of 7 Nov 2026.

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

CE MDR

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741TWDGVBDC4V Basic UDI-DI 00801741084461UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741084461 UDI-DI Date6 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0801741TWDGVBDC4V registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 00801741084461 listed 6 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00801741084461
  2. Registered EUDAMED 0801741TWDGVBDC4V

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Max-Core
Generic name
Side-notch biopsy gun handpiece/needle
Model / Ref / Catalog
MC1810
Primary DI / UDI-DI
00801741084461
Basic UDI-DI
0801741TWDGVBDC4V
FDA product code
KNW
EMDN code
A0102010102 Shearing biopsy guns
GMDN term
Side-notch biopsy gun handpiece/needle
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 18 Gauge
Length — 10 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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.

Related devices

Category: Side-notch biopsy gun handpiece/needle

Similar devices in this category

Other devices filed under SHEARING BIOPSY NEEDLES AND KITS.

Other devices from Bard Peripheral Vascular

See all devices from Bard Peripheral Vascular →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)