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Refraction Table

by Huvitz Co., Ltd. 3 variants

Ref F2VSSM-20-00001Model HRT-7000, CIT-4000

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 Number08800019601166 UDI-DI Date7 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000196RT001HG Basic UDI-DI 08800019601166UDI-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  • Withdrawn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
Hrt-7000
Generic Name
Ophthalmic instrument table, line-powered
Model / Reference
HRT-7000, CIT-4000, F2VSSM-20-00001
Primary DI / UDI-DI
08800019601166
Basic UDI-DI
88000196RT001HG
Direct Marketing DI
08800019601166
FDA Product Code
HRJ
EMDN Code
Z12129001 Ophthalmological instrument stands
GMDN Term
Ophthalmic instrument table, line-powered
Device Class
Class I
Regulation Number
886.4855
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
HRT-7000, CIT-4000
F2VSSM-20-00001
GUDID
HRT-7000

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