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Biolane Pharm Krople do Oczu (0.3% HA Eye Drops) SINGLE

by East Midlands Pharma Limited

Ref MDF-002 Formulation A (0.3%)Model MDF003- Moisturising Formulation A(0.3%HA)

Active European Union

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-50371540.3HA7XP9 Basic UDI-DIDate14 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
MDF003- Moisturising Formulation A(0.3%HA)
Model / Reference
MDF003- Moisturising Formulation A(0.3%HA), MDF-002 Formulation A (0.3%)
Primary DI / UDI-DI
D-50371540.3HA7XP9
Basic UDI-DI
B-50371540.3HA7XP9
EMDN Code
Q02030206 Eye lubricant solutions
Device Class
Class I
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000009146
Authorised representative
Advena Limited MT-AR-000000234

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Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No