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STAT6 [YE361]

by Biocare Medical

Ref ALI3244G7

STAT6 [YE361] (ALI3244G7) is a device classified as IVD General made by Biocare Medical, LLC, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00847627030122), 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-00847627030122 Basic UDI-DI 00847627030122UDI-DIDate2 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  • Withdrawn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
ALI3244G7
Primary DI / UDI-DI
00847627030122
Basic UDI-DI
B-00847627030122
EMDN code
W0102039099 Tumour markers - other
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000034581
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under TUMOUR MARKERS - OTHER.

Other devices from Biocare Medical, LLC

See all devices from Biocare Medical, LLC →

Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
Other properties (9, all answered No)