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Contec CMS50D

by Contec Medical Systems Co., Ltd.

Ref CMS50DModel CMS50DL, CMS50D

Contec CMS50D is a device classified as Class IIa in the EU and Class II in the US made by Contec Medical Systems Co., Ltd., registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI 69450401CMS50DFG), cleared under FDA 510(k) K082641 on 10 Nov 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 06945040100188), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082641

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69450401CMS50DFG Basic UDI-DI 06945040100188UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945040100188 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK082641 Date10 Nov 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69450401CMS50DFG registered 30 Mar 2026 Active
  • FDA 510(k) K082641 decided 10 Nov 2008 Active
  • FDA GUDID UDI-DI 06945040100188 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082641
  2. Listed FDA GUDID 06945040100188
  3. Registered EUDAMED 69450401CMS50DFG

Coverage

2 jurisdictions

United States of AmericaFrance
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • France since 22 Jan 2014

Last checked 27 Oct 2026.

Specification

EUDAMED · GUDID

Trade name
Pulse Oximeter EUDAMED
Contec GUDID
Generic name
Pulse oximeter
Model / reference
CMS50D, CMS50DL
Primary DI / UDI-DI
06945040100188
Basic UDI-DI
69450401CMS50DFG
Direct marketing DI
06945040100188
510(k) Number
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Pulse oximeter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2700
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
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: Pulse oximeter

Cleared under the same submission (K082641)

and 8 more cleared under K082641

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Contec Medical Systems Co., Ltd.

See all devices from Contec Medical Systems Co., Ltd. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)