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Cs 2200

by Carestream Dental LLC United States EUDAMEDGUDID

Ref 5153572

Product code EHDEMDN Z1103040102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01921552X00NL Basic UDI-DIDate12 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number60192155153570 UDI-DIDate15 Jan 2018ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Generic Name
Stationary intraoral dental x-ray system, digital
Model / Ref / Catalog
5153572, CS 2200
Primary DI / UDI-DI
60192155153570
Basic UDI-DI
01921552X00NL, 01921552X00SYS5U
FDA Product Code
EHD
EMDN Code
Z1103040102 Equipment for digital endoral radiology
GMDN Term
Stationary intraoral dental x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.1800
Market of Registration
France
Medical Purpose
CS 2100 and CS 2200 intraoral x-ray equipment are intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures, at the direction of dental professionals as diagnostic support for pediatric and adult patients.
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5153572
GUDID
CS 2200
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Related devices

Category: Dental digital imaging sensor, intraoral

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
Other properties (22)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED e1f7a6d4-0702-4fad-826e-0b53b0e9dbca 61 fields · synced 22 Oct 2026
  • FDA UDI 7ca7b3e5-c0b5-461d-81b9-3fe3ea74e1e9 34 fields · synced 30 May 2026
  • EUDAMED 60192155153570|01921552X00SYS5U 61 fields · synced 23 Oct 2026