Skip to content

Loupe with Ultra HDL™ 5.5 prescription oculars

by Metrex Research LLC.

Ref .ULTRA HDL 5.5.TTL.*, RxModel Loupe

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, self-declared

Class I: no certifier involved

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 Number06153753000002EP Basic UDI-DI 00810210821261UDI-DIDate22 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Loupe, .ULTRA HDL 5.5.TTL.*, Rx
Primary DI / UDI-DI
00810210821261
Basic UDI-DI
06153753000002EP
EMDN Code
L0316 Helmets and binocular glasses for surgeons
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000043710
Authorised representative
KERR ITALIA SRL IT-AR-000007600

Other devices from Metrex Research

See all devices from Metrex Research →

Properties

Other properties (13)

  • Sterile: No
  • 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