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ClearCap Distal Attachment

by Finemedix Co., Ltd. 3 variants

Part of a family of 10 devices: see the family page

Ref FM-CC01

ClearCap Distal Attachment (FM-CC01) is a device classified as Class IIa in the EU and Class II in the US made by Finemedix Co., Ltd., registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI 0880932735ECFX) with CE/MDR certificate 2026-MDR/QS-029 valid until 2 Jun 2031, cleared under FDA 510(k) K242134 on 20 Aug 2024 and listed in FDA GUDID since 24 Mar 2026 (UDI-DI 08809327356133), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

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.

510(k) K242134

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0880932735ECFX Basic UDI-DI 08809327356133UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809327356133 UDI-DI Date24 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK242134 Date20 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0880932735ECFX registered 8 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K242134 decided 20 Aug 2024 Active
  • FDA GUDID UDI-DI 08809327356133 listed 24 Mar 2026 Listed

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K242134
  2. Listed FDA GUDID 08809327356133
  3. Certificate issued EUDAMED 2026-MDR/QS-029
  4. Registered EUDAMED 0880932735ECFX
  5. Certificate expires EUDAMED 2026-MDR/QS-029

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Endoscope distal observation spacer, single-use
Device name
Single-Use Endoscopic Distal Attachment Cap
Model / Ref / Catalog
FM-CC01
Primary DI / UDI-DI
08809327356133
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 registration type
Standard device
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

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Similar devices in this category

Other devices filed under ENDOTHERAPY DEVICES - OTHER ACCESSORIES.

Other devices from Finemedix Co., Ltd.

See all devices from Finemedix Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)