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Auto Ref-Topographer HRKT-1

by Huvitz Co., Ltd.

Ref RTXXCL-26-00001Model HTG-1, HRKT-1

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800019600992 UDI-DI Date30 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000196TG001FB Basic UDI-DI 08800019600992UDI-DIDate19 Sep 2024RegisteredStatusActive

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  • Withdrawn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
Auto Ref-Topographer HRKT-1 GUDID
Generic Name
Automated ophthalmic refractometer
Device Name
Corneal Topographer;HTG-1, Auto Ref-Topographer;HRKT-1
Model / Reference
HTG-1, HRKT-1, RTXXCL-26-00001
Primary DI / UDI-DI
08800019600992
Basic UDI-DI
88000196TG001FB
Direct Marketing DI
08800019600992
FDA Product Code
MMQ
EMDN Code
Z12120113, Z12120123
GMDN Term
Automated ophthalmic refractometer
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.1350
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
HTG-1, HRKT-1
RTXXCL-26-00001
GUDID
HRKT-1
Device ClassEUDAMED
Class IIa
GUDID
Class I

Other devices from Huvitz Co., Ltd.

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Properties

  • Measuring Function
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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