Skip to content

plusoptiX S12R

by Plusoptix GmbH

Ref S12RModel A12C, A12R, S12C, S12R

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260184513215 UDI-DI Date20 Oct 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number426018451x12HA Basic UDI-DI 04260184513215UDI-DIDate12 Apr 2022RegisteredStatusActive

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
plusoptiX S12R EUDAMED
plusoptiX 12 GUDID
Generic Name
External ocular measurement camera
Model / Ref / Catalog
A12C, A12R, S12C, S12R
Primary DI / UDI-DI
04260184513215
Basic UDI-DI
426018451x12HA
Direct Marketing DI
04260184513215
FDA Product Code
HKO
EMDN Code
Q0299 Ophthalmic devices - other
GMDN Term
External ocular measurement camera
Device Class
Class I
Regulation Number
886.1760
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
DE-MF-000006138

Other devices from Plusoptix GmbH

See all devices from Plusoptix GmbH →

Properties

  • Measuring Function
  • Premarket Exempt
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No