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Disposable Automatic Core Biopsy Instruments

by Suzhou Leapmed Healthcare Corporation 33 variants

Ref 11301702, 11300102, 11307202, 11301002, 11302202, 11307302, 11300902, 11302902, 11304802, 11301102, 11307002, 11306702, 11306802, 11306502, 11307402, 11301402, 11301202, 11300702, 11307102Model QZDB, QZDA, FCA, QLA

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212284↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number694116500000000673 Basic UDI-DI Date7 May 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK212284 Date10 Nov 2021IssuedStatusActive

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 found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference
QZDB, 11301702, QZDA, 11300102, FCA, 11307202, 11301002, 11302202, 11307302, 11300902, QLA, 11302902, 11304802, 11301102, 11307002, 11306702, 11306802, 11306502, 11307402, 11301402, 11301202, 11300702, 11307102
Primary DI / UDI-DI
06941165040477, 06941165040316, 06941165054252, 06941165040408, 06941165040521, 06941165054269, 06941165040392, 06941165040590, 06941165040781, 06941165040415, 06941165054238, 06941165054207, 06941165054214, 06941165054184, 06941165054276, 06941165040446, 06941165040422, 06941165040378, 06941165054245
Basic UDI-DI
694116500000000673, 69411650000000056Z, 69411650000000687R, 69411650000000667M
EMDN Code
A01020199 Needles and kits for histological and cytological biopsy of soft tissues - other
Device Class
Class IIa
EU market of registration
Netherlands
Spain
Italy
Türkiye
France

Manufacturer details

EUDAMED SRN
CN-MF-000013964
Authorised representative
Share info GmbH DE-AR-000005132

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Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No