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Prontosan® Wound Spray

by B. Braun Medical AG 4 variants

Ref 400565

Active European Union

CE MDR

Valid until

1 Oct 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

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/MDR Number40392390000009252U Basic UDI-DI 07612449130908UDI-DIDate17 Sep 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2247049TD04 Active

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    29 Aug 2024
    Expires
    1 Aug 2029
  • 2247049CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    25 Sep 2024
    Expires
    1 Oct 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

EU market availability

Made available in 27 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 6 Mar 2012
  • Belgium since 6 Mar 2012
  • Bulgaria since 6 Mar 2012
  • Croatia since 6 Mar 2012
  • Cyprus since 6 Mar 2012
  • Czechia since 6 Mar 2012
  • Denmark since 6 Mar 2012
  • Estonia since 6 Mar 2012
  • Finland since 6 Mar 2012
  • France since 6 Mar 2012
  • Germany since 6 Mar 2012
  • Greece since 6 Mar 2012
  • Hungary since 6 Mar 2012
  • Ireland since 6 Mar 2012
  • Italy since 6 Mar 2012
  • Latvia since 6 Mar 2012
  • Lithuania since 6 Mar 2012
  • Luxembourg since 6 Mar 2012
  • Malta since 6 Mar 2012
  • Netherlands since 6 Mar 2012
  • Poland since 6 Mar 2012
  • Portugal since 6 Mar 2012
  • Romania since 6 Mar 2012
  • Slovakia since 6 Mar 2012
  • Slovenia since 6 Mar 2012
  • Spain since 6 Mar 2012
  • Sweden since 6 Mar 2012

Last checked 23 Oct 2026.

Specification

EUDAMED

Device Name
Prontosan Wound Spray
Model / Reference
400565
Primary DI / UDI-DI
07612449130908
Basic UDI-DI
40392390000009252U
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000017781
Authorised representative
B. Braun Melsungen AG DE-AR-000000202

Other devices from B. Braun Medical AG

See all devices from B. Braun Medical AG →

Properties

  • Incorporates Medicinal Product

Other properties (12)

  • 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