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Pulse Oximeter

by UTECH Co., Ltd. 2 variants

Ref UPM50, UPM60Model UT100、UPM50、UPM60

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697424710oximeterNY Basic UDI-DI Date13 Apr 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Handheld pulse oximeter
Model / Reference
UT100、UPM50、UPM60, UPM50, UPM60
Primary DI / UDI-DI
06974247100011, 06974247100028
Basic UDI-DI
697424710oximeterNY
Direct Marketing DI
06974247100011
06974247100028
EMDN Code
Z1203020408 Pulse oximeters
Device Class
Class IIb
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000002142
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from UTECH Co., Ltd.

See all devices from UTECH Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • Sterile: 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
  • Incorporates Medicinal Product: No