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Area Centralis (VAC)

by Volk Optical Inc.

Ref VAC

Area Centralis (VAC) is a laser lens (EU MDR Class I; FDA Class II; FDA product code HJK, Lens, Contact, Polymethylmethacrylate, Diagnostic) made by Volk Optical Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 81160801CONTACTJR) and listed in FDA GUDID since 29 Sep 2016 (UDI-DI 00811608012469), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number81160801CONTACTJR Basic UDI-DI 00811608012469UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00811608012469 UDI-DI Date29 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 81160801CONTACTJR registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 00811608012469 listed 29 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00811608012469
  2. Registered EUDAMED 81160801CONTACTJR

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  • Withdrawn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

Generic name
Laser lens, ophthalmic, surgical
Device name
Contact Laser and Diagnostic Lens
Model / reference
VAC
Primary DI / UDI-DI
00811608012469
Basic UDI-DI
81160801CONTACTJR
Direct marketing DI
00811608012469
FDA product code
HJK
EMDN code
Z12011080 Laser surgery instruments - hardware accessories
GMDN term
Laser lens, ophthalmic, surgical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.1385
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Laser lens, ophthalmic, surgical

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Volk Optical Inc.

See all devices from Volk Optical Inc. →

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (23, all answered No)