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C-Root File

by Beijing C-Root Dental Medical Devices Co., LTD. 7 variants

Part of a family of 295 devices: see the family page

Ref 015/09 19mm

C-Root File (015/09 19mm) is a device classified as Class IIa in the EU and Class I in the US made by Beijing C-Root Dental Medical Devices Co., Ltd., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 69729025804XG) and listed in FDA GUDID since 15 May 2026 (UDI-DI 06972902588143), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69729025804XG Basic UDI-DI 06972902588143UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06972902588143 UDI-DI Date15 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69729025804XG registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 06972902588143 listed 15 May 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06972902588143
  2. Registered EUDAMED 69729025804XG

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  • Withdrawn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

Trade name
C-Root File EUDAMED
C-Root GUDID
Generic name
Rotary/reciprocating endodontic file/rasp, single-use
Model / Ref / Catalog
015/09 19mm, file 015/09 19mm
Primary DI / UDI-DI
06972902588143
Basic UDI-DI
69729025804XG
FDA product code
EKS
EMDN code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
GMDN term
Rotary/reciprocating endodontic file/rasp, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
CN-MF-000033502
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTISTRY, SINGLE-USE.

Other devices from Beijing C-Root Dental Medical Devices Co., Ltd.

See all devices from Beijing C-Root Dental Medical Devices Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)