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Reusable SpO2 Sensor

by Unimed Medical Supplies, Inc

Ref U403-01

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69456648RFNE2W Basic UDI-DI 06945664800013UDI-DIDate24 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06945664800013 UDI-DI Date23 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Reusable SpO2 Sensor EUDAMED
Reusable Adult Finger Clip SpO2 Sensor EUDAMED
Unimed GUDID
Generic Name
Pulse oximeter probe, reusable
Model / Ref / Catalog
U403-01, Conmed model number: 2010
Primary DI / UDI-DI
06945664800013
Basic UDI-DI
69456648RFNE2W, B-06945664800013
Direct Marketing DI
06945664800013
510(k) Number
FDA Product Code
DQA
EMDN Code
Z1203020408 Pulse oximeters
GMDN Term
Pulse oximeter probe, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2700
EU market of registration
Germany
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000001480
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Unimed Medical Supplies, Inc.

See all devices from Unimed Medical Supplies, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Expiration Date: No