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COXO C-Smart-I Pro

by Foshan COXO Medical Instrument Co., Ltd.

Ref C-smart I pro

COXO C-Smart-I Pro is a device classified as Class IIa (EU), Unclassified (US) made by Foshan COXO Medical Instrument Co., Ltd., registered in EUDAMED on 31 Aug 2026 (Basic UDI-DI 69742678904ZW), cleared under FDA 510(k) K220829 on 18 May 2023 and listed in FDA GUDID since 5 Nov 2024 (UDI-DI 06974267890374), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220829

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69742678904ZW Basic UDI-DI 06974267890374UDI-DIDate31 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06974267890374 UDI-DI Date5 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220829 Date18 May 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69742678904ZW registered 31 Aug 2026 Active
  • FDA 510(k) K220829 decided 18 May 2023 Active
  • FDA GUDID UDI-DI 06974267890374 listed 5 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220829
  2. Listed FDA GUDID 06974267890374
  3. Registered EUDAMED 69742678904ZW

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  • Withdrawn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
Coxo
Generic name
Remotely-driven surgical/dental system drive cable
Model / reference
C-smart I pro EUDAMED
C-Smart-I Pro GUDID
Primary DI / UDI-DI
06974267890374
Basic UDI-DI
69742678904ZW
510(k) Number
FDA product code
LQY
EMDN code
Z12110101 Dental treatment units
GMDN term
Remotely-driven surgical/dental system drive cable
Device class
Class IIa EUDAMED
U GUDID
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
C-smart I pro
GUDID
C-Smart-I Pro
Device classEUDAMED
Class IIa
GUDID
U

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

Related devices

Category: Remotely-driven surgical/dental system drive cable

Cleared under the same submission (K220829)

Similar devices in this category

Other devices filed under DENTAL TREATMENT UNITS.

Other devices from Foshan COXO Medical Instrument Co., Ltd.

See all devices from Foshan COXO Medical Instrument Co., Ltd. →

Properties

  • Sterilise before use
  • Measuring function
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)