Skip to content

XpandNT X1 Iris Speculum

by International Science and Technology LP DBA Diamatrix Ltd

Ref 346722

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00813059013934 Basic UDI-DI 00813059013934UDI-DIDate24 Apr 2025RegisteredStatusActive

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  • Withdrawn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
346722
Primary DI / UDI-DI
00813059013934
Basic UDI-DI
B-00813059013934
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000024814
Authorised representative
Advena Limited MT-AR-000000234

From the manufacturer

Manufacturer's product page: Xpand

Other devices from International Science and Technology LP DBA Diamatrix Ltd

See all devices from International Science and Technology LP DBA Diamatrix Ltd →

Properties

  • Sterile

Other properties (10)

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