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Total Laboratory Automation

by Maccura Medical Instrument Co., Ltd. EUDAMED

Active European Union

Ref CH9304011Model IOM-03, IOM-06, IOM-07, ICM-01

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6972168356012AS Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Total Laboratory Automation (LABAS MIX）
Model / Reference
IOM-03, IOM-06, IOM-07, ICM-01, CH9304011
Primary DI / UDI-DI
06972168357156
Basic UDI-DI
6972168356012AS
Direct Marketing DI
06972168357156
EMDN Code
W02069099 Various sample processing instruments - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000028087
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Maccura Medical Instrument Co., Ltd.

See all devices from Maccura Medical Instrument Co., Ltd. →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No