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ClearHemograsper

by Finemedix Co., Ltd. 2 variants

Ref FM-HG0001(1820)Model ClearHemograsper

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

CE MDR CE MDD

Valid until

2 Jun 2031

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier 3EC International a.s.

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 NumberB-08809327353293 Basic UDI-DI 08809327353293UDI-DIDate16 Sep 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08809327353293 Basic UDI-DI 08809327353293UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809327353293 UDI-DI Date24 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-028 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    2 Jun 2026
    Expires
    2 Jun 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use
Device Name
Single-Use Electrosurgical Hemostatic Forceps
Model / Ref / Catalog
ClearHemograsper, FM-HG0001(1820)
Primary DI / UDI-DI
08809327353293
Basic UDI-DI
B-08809327353293, 0880932735HGGG
510(k) Number
FDA Product Code
KGE
EMDN Code
K0201010301 Open electrosurgery electrodes, single-use
GMDN Term
Endoscopic electrosurgical electrode, monopolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4300
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000021680
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Finemedix

See all devices from Finemedix →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No