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Confianzza

by Waco Bi̇omedi̇kal Ve Laboratuvar San. Ti̇c. Ltd. Şti̇. 34 variants

Ref C-WA305Model CONFIANZZA Oxidized Regenerated Cellulose Layer Type 10,2*10,2 cm

Active European Union

CE MDD

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 23 Oct 2026. What this means

Overview

The CONFIANZZA medical device, developed by WACO BİOMEDİKAL VE LABORATUVAR SAN. TİC. LTD. ŞTİ., is a Class III implantable device used for the treatment of endocrine disorders. It features an oxidized regenerated cellulose layer and can be sterilized using the gamma sterilization method. The CONFIANZZA has been designed to provide a reliable and effective solution for patients requiring hormone replacement therapy.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682662170615 Basic UDI-DI 08682662170615UDI-DIDate15 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
CONFIANZZA Oxidized Regenerated Cellulose Layer Type 10, 2*10, 2 cm, C-WA305
Primary DI / UDI-DI
08682662170615
Basic UDI-DI
B-08682662170615
EMDN Code
M040501 Polysaccharide haemostatic dressings
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TR-MF-000031049

Other devices from Waco Bi̇omedi̇kal Ve Laboratuvarsan. Ti̇c. Ltd. Şti̇.

See all devices from Waco Bi̇omedi̇kal Ve Laboratuvarsan. Ti̇c. Ltd. Şti̇. →

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