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Quantia ASO

by Biokit S.A.

Ref 6K38-02

Quantia ASO (6K38-02) is a device classified as IVD General made by Biokit, S.A., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-00380740157500), active as of 7 Nov 2026.

Active European Union

CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00380740157500 Basic UDI-DI 00380740157500UDI-DIDate3 Nov 2026RegisteredStatusActive

Official records

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / reference
6K38-02
Primary DI / UDI-DI
00380740157500
Basic UDI-DI
B-00380740157500
EMDN code
W01021104 Anti-streptolysin o (quantitative)
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000002406

Similar devices in this category

Other devices filed under ANTI-STREPTOLYSIN O (QUANTITATIVE).

Other devices from Biokit, S.A.

See all devices from Biokit, S.A. →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (7, all answered No)