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Complete-Chiba MR

by Sterylab SRL 8 variants

Ref CCH2109MR

Complete-Chiba MR (CCH2109MR) is a device classified as Class IIa in the EU and Class II in the US made by Sterylab SRL, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 803395922FT001BIOPSIAME), cleared under FDA 510(k) K051506 on 27 Jul 2005 and listed in FDA GUDID since 2 Oct 2019 (UDI-DI 08033959222942), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K051506

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 Number803395922FT001BIOPSIAME Basic UDI-DI 08033959222942UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033959222942 UDI-DI Date2 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK051506 Date27 Jul 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803395922FT001BIOPSIAME registered 7 Oct 2026 Active
  • FDA 510(k) K051506 decided 27 Jul 2005 Active
  • FDA GUDID UDI-DI 08033959222942 listed 2 Oct 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K051506
  2. Listed FDA GUDID 08033959222942
  3. Registered EUDAMED 803395922FT001BIOPSIAME

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  • Withdrawn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

Trade name
Complete-Chiba EUDAMED
Complete-Chiba MR GUDID
Generic name
Body aspiration needle, single-use
Device name
Aghi per Biospia Su Tessuti Molli
Model / Ref / Catalog
CCH2109MR, COMPLETE-CHIBA MR
Description
Chiba type needle with quincke point 21 G; 9 cm
Primary DI / UDI-DI
08033959222942
Basic UDI-DI
803395922FT001BIOPSIAME
510(k) Number
FDA product code
FCG, KNW
EMDN code
A01020102 Aspiration fine needles and kits
GMDN term
Body aspiration needle, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CCH2109MR
GUDID
COMPLETE-CHIBA MR
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: Body aspiration needle, single-use

Cleared under the same submission (K051506)

and 8 more cleared under K051506

Similar devices in this category

Other devices filed under ASPIRATION FINE NEEDLES AND KITS.

Other devices from Sterylab SRL

  • Mammorep Zeta

    Class II

  • Complete-Chiba

    Class II

  • Ata-Cut

    Class II

  • Full-Opty

    Class II

See all devices from Sterylab SRL →

Properties

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