Skip to content

ClearTip FM-CTB001

by Finemedix Co., Ltd.

Part of a family of 30 devices: see the family page

Ref FM-CTB001Model ClearTip

ClearTip FM-CTB001 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 16 Sep 2026 (Basic UDI-DI B-08809327352951) with CE/MDR certificate 2026-MDR/QS-029 valid until 2 Jun 2031, cleared under FDA 510(k) K180363 on 1 Nov 2018 and listed in FDA GUDID since 12 Apr 2019 (UDI-DI 08809327352951), active as of 24 Oct 2026.

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

CE MDR CE MDD 510(k)

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.

510(k) K180363

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08809327352951 Basic UDI-DI 08809327352951UDI-DIDate16 Sep 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08809327352951 Basic UDI-DI 08809327352951UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809327352951 UDI-DI Date12 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180363 Date1 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809327352951 registered 16 Sep 2026 Active· +2 more in the status table
  • FDA 510(k) K180363 decided 1 Nov 2018 Active
  • FDA GUDID UDI-DI 08809327352951 listed 12 Apr 2019 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) K180363
  2. Listed FDA GUDID 08809327352951
  3. Certificate issued EUDAMED 2026-MDR/QS-029
  4. Registered EUDAMED B-08809327352951
  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, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ClearTip
Generic name
Flexible endoscopic biopsy handpiece/needle
Device name
Endoscopic Ultrasound-Guided Tissue Acquisition Needle
Model / reference
FM-CTB001, ClearTip
Primary DI / UDI-DI
08809327352951
Basic UDI-DI
B-08809327352951, 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 registration type
Legacy device (under a directive)
Standard device
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

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.

Related devices

Category: Flexible endoscopic biopsy handpiece/needle

Cleared under the same submission (K180363)

and 1 more cleared under K180363

Similar devices in this category

Other devices filed under ASPIRATION FINE NEEDLES AND KITS.

Other devices from Finemedix Co., Ltd.

See all devices from Finemedix Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (19, all answered No)