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EstaCore Automatic Biopsy Needle

by Geotek Medikal Ve Saglik Hizmetleri Tic.san.ltd.sti

Ref GEC1216, GEP2009-X, GEP1209-X, GEP2016S-X, GEP1210-X, GEP1220-X, GEP1609-X, GEP1809-X, GEP1409-X, GEC2016-X, GEP1216S-X, GEC1210, GEP1212-X, GEP1212, GEP1216-X, GEP1212S-X, GEP1609S-X, GEP1216, GEP1809S-X, GEP1409S-X, GEP2016-X, GEP1830-S, GEP1409-S, GEP1212-S, GEP1609-S, GEP1812, GEP2015, GEP1809-S, GEP1412Model Biopsy Needles

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number869915834BN6B Basic UDI-DI Date22 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08683255230372 UDI-DI Date1 Sep 2023ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
EstaCore Automatic Biopsy Needle EUDAMED
EstaCore Pro Automatic Biopsy Needle with Coaxial EUDAMED
EstaCore Automatic Biopsy Needle with Coaxial EUDAMED
EstaCore Pro Automatic Biopsy Needle EUDAMED
Estacore-Pro Automatic Biopsy Needle GUDID
Generic Name
Side-notch biopsy gun handpiece/needle
Device Name
Biopsy Needles
Model / Ref / Catalog
Biopsy Needles, GEC1216, GEP2009-X, GEP1209-X, GEP2016S-X, GEP1210-X, GEP1220-X, GEP1609-X, GEP1809-X, GEP1409-X, GEC2016-X, GEP1216S-X, GEC1210, GEP1212-X, GEP1212, GEP1216-X, GEP1212S-X, GEP1609S-X, GEP1216, GEP1809S-X, GEP1409S-X, GEP2016-X, GEP1809-S, GEP2015, GEP1609-S, GEP1409-S, GEP1812, GEP1830-S, GEP1412, GEP1212-S
Primary DI / UDI-DI
08683255230372, 08681672054915, 08683255230860, 08681672055936, 08683255230877, 08683255230907, 08681672054892, 08681672054908, 08683255234646, 08683255234530, 08681672055448, 08683255230358, 08683255234639, 08683255234615, 08683255230891, 08681672055332, 08681672055714, 08683255230785, 08681672055912, 08681672055691, 08681672054922, 08683255231676, 08681672052232, 08683255231478, 08681672052454, 08681672052157, 08681672052638, 08681672052027, 08681672054953
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 handpiece/needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
EU 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

Manufacturer details

EUDAMED SRN
TR-MF-000026388

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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