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ClearTip

by Finemedix Co., Ltd. 10 variants

Ref FM-CTB012

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 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 Number0880932735CTGT Basic UDI-DI 08809327355969UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809327355969 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 24 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  • Withdrawn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
Flexible endoscopic biopsy handpiece/needle
Device Name
Endoscopic Ultrasound-Guided Tissue Acquisition Needle
Model / Ref / Catalog
FM-CTB012
Primary DI / UDI-DI
08809327355969
Basic UDI-DI
0880932735CTGT
510(k) Number
FDA Product Code
FCG
EMDN Code
A01020102 Aspiration fine needles and kits
GMDN Term
Flexible endoscopic biopsy handpiece/needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
EU market of registration
Italy
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

Other devices from Finemedix Co., Ltd.

See all devices from Finemedix Co., Ltd. →

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