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Cs 1200

by Carestream Dental LLC 2 variants

Cs 1200 (9G5275) is a Class I device made by Carestream Dental LLC, cleared under FDA 510(k) K112321 on 10 Nov 2011, registered in EUDAMED and listed in FDA GUDID since 1 Mar 2019 (UDI-DI 60192155950438), 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) K112321

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number60192155950438 UDI-DI Date1 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112321 Date10 Nov 2011DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K112321 decided 10 Nov 2011 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 60192155950438 listed 1 Mar 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112321
  2. Listed FDA GUDID 60192155950438

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  • Withdrawn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

Generic name
Flexible video stomatoscope
Model / Ref / Catalog
CS 1200, 9G5275
Primary DI / UDI-DI
60192155950438
510(k) Number
FDA product code
EIA
GMDN term
Flexible video stomatoscope
Device class
Class I
Regulation number
872.6640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible video stomatoscope

Cleared under the same submission (K112321)

Similar devices

Also classified as Flexible video stomatoscope.

Similar devices

Other devices filed under FDA product code EIA (Unit, Operative Dental).

Other devices from Carestream Dental LLC

See all devices from Carestream Dental LLC →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)