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Huvitz

by Huvitz Co., Ltd. 3 variants

Ref E2DDAG-21-00002Model HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF

Huvitz (E2DDAG-21-00002) is a Class I device made by Huvitz Co., Ltd., registered in EUDAMED on 21 Feb 2022 (Basic UDI-DI 88000196DC0018X) and listed in FDA GUDID since 10 May 2019 (UDI-DI 08800019600237), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000196DC0018X Basic UDI-DI 08800019600237UDI-DIDate21 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019600237 UDI-DI Date10 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000196DC0018X registered 21 Feb 2022 Active
  • FDA GUDID UDI-DI 08800019600237 listed 10 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019600237
  2. Registered EUDAMED 88000196DC0018X

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  • Withdrawn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
Huvitz EUDAMED
Chart Projector HCP-7000 GUDID
Generic name
Visual acuity projector
Device name
Digital Chart, Chart Projector, Visual Acuity Chart System
Model / Ref / Catalog
HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF, E2DDAG-21-00002
Description
chart projector is intended to be used to check eye optometry
Primary DI / UDI-DI
08800019600237
Basic UDI-DI
88000196DC0018X
Direct marketing DI
08800019600237
FDA product code
HOS
EMDN code
Z1212012001 Visual functional assessment equipment
GMDN term
Visual acuity projector
Device class
Class I
Regulation number
886.1680
System or procedure pack
System which is a device in itself
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
Model / referenceEUDAMED
HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF
E2DDAG-21-00002
GUDID
HCP-7000

Manufacturer details

EUDAMED SRN
KR-MF-000015802
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT.

Other devices from Huvitz Co., Ltd.

See all devices from Huvitz Co., Ltd. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)