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Herpatch

by Sylphar nv 2 variants

Ref 10 ml

Active European Union

CE MDD

Valid until

No date given

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/MDD NumberB-05425012531901 Basic UDI-DI 05425012531901UDI-DIDate29 Oct 2021RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device name
Herpatch Mouth Ulcer Gel
Model / reference
10 ml
Primary DI / UDI-DI
05425012531901
Basic UDI-DI
B-05425012531901
EMDN code
M040499 Dressings for wounds, sores and ulcerations - other
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
BE-MF-000000732

Related devices

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

Other devices from Sylphar nv

Properties

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No