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koplight S blade/koplight HT S blade

by Yasui Co., Ltd. 8 variants

Ref KS-6HS

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

CE MDR

Valid until

19 Sep 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberJP24/00000267 Date22 Sep 2025IssuedStatusActive expires 19 Sep 2029
United StatesGUDID listing GUDID Number04562231093528 UDI-DI Date19 Aug 2024ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • JP24/00000267 Active Amended

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    22 Sep 2025
    Expires
    19 Sep 2029
    Reason
    Ar data change

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  • Withdrawn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
koplight S blade/koplight HT S blade EUDAMED
KS-6HS koplight HT S blade GUDID
Generic Name
Hand-held surgical retractor, single-use
Model / Reference
KS-6HS
Primary DI / UDI-DI
04562231093528
Basic UDI-DI
456223109retractor84
FDA Product Code
GAD
EMDN Code
K01020106 Minimally invasive surgery spreaders and retractors, single-use
GMDN Term
Hand-held surgical retractor, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Width — 25.0 Millimeter
Length — 122.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
JP-MF-000010113
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Yasui Co., Ltd.

See all devices from Yasui Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No