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ClearCap Distal Attachment

by Finemedix Co., Ltd.

Ref FM-CC06

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

CE MDR

Valid until

2 Jun 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier 3EC International a.s.

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
European UnionCE/MDR EUDAMED Number0880932735ECFX Basic UDI-DI 08809327356188UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809327356188 UDI-DI Date24 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-029 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 23 Oct 2026.

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  • Withdrawn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

Generic Name
Endoscope distal observation spacer, single-use
Device Name
Single-Use Endoscopic Distal Attachment Cap
Model / Ref / Catalog
FM-CC06
Primary DI / UDI-DI
08809327356188
Basic UDI-DI
0880932735ECFX
510(k) Number
FDA Product Code
OCX
EMDN Code
K0180 Endotherapy devices - other accessories
GMDN Term
Endoscope distal observation spacer, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

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  • ClearHemograsper

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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