Skip to content

Explore 8

by Technologies HumanWare Inc. 2 variants

Ref NOM-400Model Electronic Magnifiers

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 Number83061100003JD Basic UDI-DI 18306110000480UDI-DIDate3 Dec 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
Explore Handheld Electronic Magnifier
Model / Reference
Electronic Magnifiers, NOM-400
Primary DI / UDI-DI
18306110000480
Basic UDI-DI
83061100003JD
Direct Marketing DI
18306110000480
EMDN Code
Y210603 Video magnifiers
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CA-MF-000022852
Authorised representative
CEpartner4U NL-AR-000000111

Other devices from Technologies HumanWare Inc.

See all devices from Technologies HumanWare Inc. →

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