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FreeStyle Optium Neo H Blood Glucose and Ketone Monitoring System

by Abbott Diabetes Care Ltd 5 variants

Ref 77271-01

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5021791PHM0001FK Basic UDI-DI 05021791004850UDI-DIDate23 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
FreeStyle Precision Neo H Blood Glucose and Ketone Meter or Monitoring System / FreeStyle Optium Neo H Blood Glucose and Ketone Meter or Monitoring System
Model / Reference
77271-01
Primary DI / UDI-DI
05021791004850
Basic UDI-DI
5021791PHM0001FK
Direct Marketing DI
05021791005178
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
GB-MF-000029309
Authorised representative
Abbott B.V. NL-AR-000012577

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Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (8)

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