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Surfasoft®

by Haromed B.V. 3 variants

Ref 1015S

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number54200791SURFASOFTPS Basic UDI-DI 05420079100015UDI-DIDate21 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SURFASOFT® monofilament non-adherent micro-perforated protective contact layer 10 cm x 15 cm
Model / Reference
1015S
Primary DI / UDI-DI
05420079100015
Basic UDI-DI
54200791SURFASOFTPS
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000040766

Related devices

Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial

Other devices from Haromed B.V.

Properties

  • Sterile

Other properties (12)

  • 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