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FIABiomed Precisa Blood Glucose Test Strip

by HMD Biomedical Inc. 6 variants

Ref 3S-01-350036Model Precisa

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04260236851081 Basic UDI-DI 04260236851081UDI-DIDate23 Apr 2025RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
FIABiomed
Model / Reference
Precisa, 3S-01-350036
Primary DI / UDI-DI
04260236851081
Basic UDI-DI
B-04260236851081
EMDN Code
W0101060101 Glucose test strips
Device Class
Class IVD Annex II List B

Manufacturer details

EUDAMED SRN
TW-MF-000032809
Authorised representative
Luana Med. B.V. NL-AR-000002750

Other devices from Hmd Biomedical Inc.

See all devices from Hmd Biomedical Inc. →

Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • Surgical Instrument: No