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Flaminal Hydro

by Flen Health Pharma

Ref 1010-C

Active European Union

CE MDR

Valid until

1 Nov 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5420013FlaminalHydro01LZ Basic UDI-DIDate23 Dec 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2253359CE01 Active Amended

    Quality management system EU MDR

    Notified body
    DEKRA Certification B.V. 0344
    Issued
    8 Dec 2025
    Expires
    1 Nov 2027
    Reason
    Mnf ar change

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Flaminal Hydro
Model / Reference
1010-C
Primary DI / UDI-DI
05420013502868
Basic UDI-DI
5420013FlaminalHydro01LZ
EMDN Code
M04040202 Alginate dressings, combined with other substances
Device Class
Class IIb
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
BE-MF-000000258

Other devices from Flen Health Pharma

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    Class IIb

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    Class IIa

  • Flaminal Forte

    Class IIb

  • Flaminal Forte

    Class IIb

  • Flaminal Forte

    Class IIb

  • Flaminal Forte

    Class IIb

See all devices from Flen Health Pharma →

Properties

Other properties (13)

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