Skip to content

Disposable Semi Automatic Biopsy Instruments

by Suzhou Leapmed Healthcare Corporation 6 variants

Ref 11100802, 11100202, 11100102, 11100602, 11101802, 11101602, 11101902Model Type A, Type B

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 Number69411650000000016R Basic UDI-DI Date7 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Type A, 11100802, 11100202, 11100102, 11100602, Type B, 11101802, 11101602, 11101902
Primary DI / UDI-DI
06941165040903, 06941165040842, 06941165040835, 06941165040880, 06941165041009, 06941165040989, 06941165041016
Basic UDI-DI
69411650000000016R, 69411650000000026T
EMDN Code
A01020199 Needles and kits for histological and cytological biopsy of soft tissues - other
Device Class
Class IIa
EU market of registration
Netherlands
Türkiye
Spain

Manufacturer details

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

Other devices from Suzhou Leapmed Healthcare Corporation

See all devices from Suzhou Leapmed Healthcare Corporation →

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