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Cs 1200

by Carestream Dental LLC

Ref 6559991

Cs 1200 (6559991) is a Class I device made by Carestream Dental LLC, registered in EUDAMED on 22 Mar 2022 (Basic UDI-DI 01921551200GL), cleared under FDA 510(k) K112321 on 10 Nov 2011 and listed in FDA GUDID since 15 Feb 2019 (UDI-DI 60192156559999), 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) K112321

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 Number01921551200GL Basic UDI-DI 60192156559999UDI-DIDate22 Mar 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number60192156559999 UDI-DI Date15 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112321 Date10 Nov 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 01921551200GL registered 22 Mar 2022 Active
  • FDA 510(k) K112321 decided 10 Nov 2011 Active
  • FDA GUDID UDI-DI 60192156559999 listed 15 Feb 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K112321
  2. Listed FDA GUDID 60192156559999
  3. Registered EUDAMED 01921551200GL

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  • Withdrawn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
6559991, CS 1200
Primary DI / UDI-DI
60192156559999
Basic UDI-DI
01921551200GL
510(k) Number
FDA product code
EIA
EMDN code
Z12110101 Dental treatment units
GMDN term
Flexible video stomatoscope
Device class
Class I
Regulation number
872.6640
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
6559991
GUDID
CS 1200

Manufacturer details

EUDAMED SRN
US-MF-000003727
Authorised representative
TROPHY FR-AR-000001797

Related devices

Category: Dental delivery system

Similar devices

Also classified as Dental delivery system.

Similar devices in this category

Other devices filed under DENTAL TREATMENT UNITS.

Other devices from Carestream Dental LLC

See all devices from Carestream Dental LLC →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)