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OxyM

by nice Neotech Medical Systems Pvt. Ltd., 2 variants

Ref nice 5010Model nice 5005, nice 5010

Active European Union

CE MDR

Valid until

1 Oct 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

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 Number1000170230 Date15 Aug 2024IssuedStatusActive EUDAMED: not on the EU market expires 1 Oct 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000170230 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    15 Aug 2024
    Expires
    1 Oct 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Air Oxygen Blender
Model / Reference
nice 5005, nice 5010
Primary DI / UDI-DI
08908003989235
Basic UDI-DI
8908003989nice5010L3
EMDN Code
R060202 Oxygen administration humidification systems
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
IN-MF-000010243
Authorised representative
Amstermed B.V. NL-AR-000001971

Other devices from nice Neotech Medical Systems Pvt. Ltd.,

See all devices from nice Neotech Medical Systems Pvt. 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