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Arterial Blood Gas Sampler

by Hubei MeterOmega Technology LTD 38 variants

Ref 115195, 115196, 115198Model ABS01A-FC, ABS02A-FC, ABS03A-FC

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 Number697461717ABGAFGHE Basic UDI-DI 06974617172167UDI-DIDate4 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  • Withdrawn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
Arterial Blood Gas Sampler
Model / Reference
ABS01A-FC, ABS02A-FC, ABS03A-FC, 115195, 115196, 115198
Primary DI / UDI-DI
06974617172167
Basic UDI-DI
697461717ABGAFGHE
EMDN Code
A02010501 Blood gas analysis, syringes with needle w/o safety system and kits
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000016732
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

Other devices from Hubei MeterOmega Technology LTD

See all devices from Hubei MeterOmega Technology LTD →

Properties

  • Sterile
  • CMR Substance
  • Animal Tissues

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No