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Huvitz

by Huvitz Co., Ltd. 3 variants

Ref XXXXCL-25-00001Model HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800019601074 UDI-DI Date19 Nov 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000196DC0018X Basic UDI-DI 08800019601074UDI-DIDate21 Feb 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  • Withdrawn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
Huvitz EUDAMED
Visual Acuity Chart System HDC-100 GUDID
Generic Name
Visual acuity projector
Device Name
Digital Chart, Chart Projector, Visual Acuity Chart System
Model / Reference
HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF, XXXXCL-25-00001
Primary DI / UDI-DI
08800019601074
Basic UDI-DI
88000196DC0018X
Direct Marketing DI
08800019601074
FDA Product Code
HOX
EMDN Code
Z1212012001 Visual functional assessment equipment
GMDN Term
Visual acuity projector
Device Class
Class I
Regulation Number
886.1150
EU market of registration
France
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
XXXXCL-25-00001
GUDID
HDC-100

Manufacturer details

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

Other devices from Huvitz Co., Ltd.

See all devices from Huvitz Co., Ltd. →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

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
  • Measuring Function: 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