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EarlyFound

by S&T BioMed CO., LTD. EUDAMED

Active European Union

Ref STBP01E1-1P

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-STBP01E1-1PBU Basic UDI-DIDate19 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
EarlyFound MMP-1 ELISA KIT
Model / Reference
STBP01E1-1P
Primary DI / UDI-DI
D-STBP01E1-1PBU
Basic UDI-DI
B-STBP01E1-1PBU
EMDN Code
W0102039099 Tumour markers - other
Device Class
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
TW-MF-000058409
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from S&T BioMed CO., LTD.

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No