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Kratz-Barraquer Heavy Wire Speculum with Open Blade Length 10mm

by ZOMEX Instruments Company (Pvt.) Ltd

Ref ZIC-1004

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G734ZIC1004WIRESPECUL6Z Basic UDI-DI G734ZIC1004WIRESPECUL6ZUDI-DIDate7 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  • Withdrawn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

Device Name
Kratz-Barraquer Heavy Wire Speculum with Open Blade Length 14mm
Model / Reference
ZIC-1004
Primary DI / UDI-DI
G734ZIC1004WIRESPECUL6Z
Basic UDI-DI
++G734ZIC1004WIRESPECUL6Z
Direct Marketing DI
G734ZIC1004WIRESPECUL6Z
EMDN Code
L149004 ENT speculums, reusable
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
PK-MF-000045170
Authorised representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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