Skip to content

Neochromes ONE HI 1.67 UC Camber Gray 7

by Advanced Photochromics LLC

Ref 0265024042Model 167CamberOne

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081016109167CamberOneW9 Basic UDI-DI 18404975007641UDI-DIDate23 Apr 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  • Withdrawn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

Device Name
1.67 SemiFinished Camber lenses version One
Model / Reference
167CamberOne, 0265024042
Primary DI / UDI-DI
18404975007641
Basic UDI-DI
081016109167CamberOneW9
EMDN Code
Q0210010101 Monofocal organic ophthalmic lenses
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000043049
Authorised representative
INDIZEN OPTICAL TECHNOLOGIES S.L.U ES-AR-000042818

Other devices from Advanced Photochromics LLC

See all devices from Advanced Photochromics LLC →

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