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FireCR Dental FR11

by Digiray Corp.

Ref FireCR Dental

FireCR Dental FR11 (CG-702) is a device classified as Class IIa in the EU and Class II in the US made by Digiray Corp., registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI 08809466040213P), cleared under FDA 510(k) K131442 on 6 Sep 2013 and listed in FDA GUDID since 22 Jun 2016 (UDI-DI 08809466040214), 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) K131442

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 Number08809466040213P Basic UDI-DI 08809466040214UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809466040214 UDI-DI Date22 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131442 Date6 Sep 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08809466040213P registered 11 Jun 2026 Active
  • FDA 510(k) K131442 decided 6 Sep 2013 Active
  • FDA GUDID UDI-DI 08809466040214 listed 22 Jun 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131442
  2. Listed FDA GUDID 08809466040214
  3. Registered EUDAMED 08809466040213P

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  • Withdrawn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
FireCR Dental
Generic name
Computed radiography digital imaging scanner
Model / Ref / Catalog
FireCR Dental EUDAMED
FR11 GUDID
CG-702 GUDID
Primary DI / UDI-DI
08809466040214
Basic UDI-DI
08809466040213P
Direct marketing DI
08809466040214
510(k) Number
FDA product code
MUH
EMDN code
Z11060201 Single-input computed radiography (cr) systems
GMDN term
Computed radiography digital imaging scanner
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.1800
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Weight — 4.7 Kilogram
Width — 12.0 Centimeter
Length — 31.8 Centimeter
Height — 26.5 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FireCR Dental
GUDID
FR11
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: Computed radiography digital imaging scanner

Similar devices in this category

Other devices filed under SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS.

Other devices from Digiray Corp.

See all devices from Digiray Corp. →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)