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Maxicore-M Automatic Biopsy Gun Needle GPN1610-M

by Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi EUDAMEDGUDID

Active European Union

Ref GPN1610-MModel Biopsy Needles

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number869915834BN6B Basic UDI-DIDate22 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08681672050412 UDI-DIDate1 Sep 2023ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Maxicore-M Automatic Biopsy Gun Needle
Generic Name
Side-notch biopsy gun needle
Device Name
Biopsy Needles
Model / Ref / Catalog
GPN1610-M, Biopsy Needles
Primary DI / UDI-DI
08681672050412
Basic UDI-DI
869915834BN6B
FDA Product Code
KNW
EMDN Code
A01020199 Needles and kits for histological and cytological biopsy of soft tissues - other
GMDN Term
Side-notch biopsy gun needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
Market of Registration
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Geotek Medikal Ve Saglik Hizmetleri Ticaret Sanayi Limited Sirketi

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No