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Contec CMS50I

by Contec Medical Systems Co., Ltd.

Ref CMS50I

Contec CMS50I 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 30 Jul 2026 (Basic UDI-DI B-06945040100676), cleared under FDA 510(k) K090671 on 11 Jun 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 06945040100676), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090671

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06945040100676 Basic UDI-DI 06945040100676UDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945040100676 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090671 Date11 Jun 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06945040100676 registered 30 Jul 2026 Active
  • FDA 510(k) K090671 decided 11 Jun 2009 Active
  • FDA GUDID UDI-DI 06945040100676 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090671
  2. Listed FDA GUDID 06945040100676
  3. Registered EUDAMED B-06945040100676

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  • Withdrawn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
CMS50I
Primary DI / UDI-DI
06945040100676
Basic UDI-DI
B-06945040100676
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
Greece
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 (K090671)

and 8 more cleared under K090671

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)