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Contec CMS50D1

by Contec Medical Systems Co., Ltd.

Ref CMS50D1

Contec CMS50D1 is a pulse oximeter (EU MDD Class IIb; FDA Class II; FDA product code DQA, Oximeter) made by Contec Medical Systems Co., Ltd., registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI B-06945040100645) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 06945040100645), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06945040100645 Basic UDI-DI 06945040100645UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945040100645 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06945040100645 registered 7 Jul 2026 Active
  • FDA GUDID UDI-DI 06945040100645 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06945040100645
  2. Registered EUDAMED B-06945040100645

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Pulse Oximeter EUDAMED
Contec GUDID
Generic name
Pulse oximeter
Model / reference
CMS50D1
Primary DI / UDI-DI
06945040100645
Basic UDI-DI
B-06945040100645
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
Poland
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

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)