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MERILISA HBsAg

by Meril Diagnostics Pvt. Ltd. EUDAMED

Active European Union

Ref HPBELI-03

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-18906074569421 Basic UDI-DIDate18 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
MERILISA HBsAg
Model / Reference
HPBELI-03
Primary DI / UDI-DI
18906074569421
Basic UDI-DI
B-18906074569421
EMDN Code
W0105020201 Hepatitis b surface antigen
Device Class
Class IVD Annex II List A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000028158
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Meril Diagnostics Pvt. Ltd.

See all devices from Meril Diagnostics Pvt. Ltd. →

Properties

Show properties
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No