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KatraCore Automatic Biopsy Needle w/Coaxial

by Geotek Medikal Ve Saglik Hizmetleri Tic.san.ltd.sti 7 variants

Ref GKR1416-X, GKR1820-X, GKR1810-X, GKR2015-X, GKR1610-X, GKR1612-X, GKR1625-X, GKR2020-X, GKR1420-X, GKR1415-X, GKR1410-X, GKR2010-X, GKR1620-X, GKR1615-X, GKR1409-X, GKR1816-XModel Biopsy Needles

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number869915834BN6B Basic UDI-DI Date22 Mar 2024RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Biopsy Needles
Model / Reference
Biopsy Needles, GKR1416-X, GKR1820-X, GKR1810-X, GKR2015-X, GKR1610-X, GKR1612-X, GKR1625-X, GKR2020-X, GKR1420-X, GKR1415-X, GKR1410-X, GKR2010-X, GKR1620-X, GKR1615-X, GKR1409-X, GKR1816-X
Primary DI / UDI-DI
08699158347536, 08699158347734, 08699158347673, 08699158347796, 08699158347550, 08683255230471, 08683255230495, 08699158347819, 08683255230464, 08699158346959, 08699158346935, 08699158347772, 08699158347611, 08699158347574, 08699158346911, 08699158347710
Basic UDI-DI
869915834BN6B
EMDN Code
A01020199 Needles and kits for histological and cytological biopsy of soft tissues - other
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026388

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Properties

  • Sterile

Other properties (12)

  • 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