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CONTEC CMS50-Pro

by Contec Medical Systems Co., Ltd.

Ref CMS50-Pro

CONTEC CMS50-Pro is a device classified as Class IIb in the EU and Class II in the US made by Contec Medical Systems Co., Ltd., registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI B-06945040105794), cleared under FDA 510(k) K082641 on 10 Nov 2008 and listed in FDA GUDID since 31 May 2021 (UDI-DI 06945040105794), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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/MDD EUDAMED NumberB-06945040105794 Basic UDI-DI 06945040105794UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945040105794 UDI-DI Date31 May 2021ListedStatusListed 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 B-06945040105794 registered 7 Jul 2026 Active
  • FDA 510(k) K082641 decided 10 Nov 2008 Active
  • FDA GUDID UDI-DI 06945040105794 listed 31 May 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082641
  2. Listed FDA GUDID 06945040105794
  3. Registered EUDAMED B-06945040105794

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Pulse Oximeter EUDAMED
Contec GUDID
Generic name
Pulse oximeter
Model / reference
CMS50-Pro
Primary DI / UDI-DI
06945040105794
Basic UDI-DI
B-06945040105794
510(k) Number
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Pulse oximeter
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 (20, all answered No)