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Wa-101

by MEDNIS CO., Ltd. 2 variants

Ref WA-101_B6M114

Active European Union

CE MDR

Valid until

31 Jan 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8800179300008ZV Basic UDI-DI 08800179300848UDI-DIDate9 May 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-005 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    31 Jan 2024
    Expires
    31 Jan 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SpO2 Sensor Probe
Model / Reference
WA-101_B6M114
Primary DI / UDI-DI
08800179300848
Basic UDI-DI
8800179300008ZV
EMDN Code
C900301 Pulse oximeter sensors
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000024165
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from MEDNIS CO., Ltd.

  • Wa-109

    Class IIb

  • Wa-103

    Class IIb

  • Wa-102

    Class IIb

  • Wa-108

    Class IIb

  • Wa-110

    Class IIb

  • Wa-112

    Class IIb

See all devices from MEDNIS CO., Ltd. →

Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No