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Prontosan® Solution

by B. Braun Medical AG 14 variants

Ref 400423

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 Number40392390000009242S Basic UDI-DI 04046963787271UDI-DIDate17 Sep 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 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
  • 2247049TD01 Active Amended

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    29 Nov 2023
    Expires
    1 Oct 2028
    Reason
    Other

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  • Withdrawn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 Apr 2010
  • Belgium since 6 Apr 2010
  • Bulgaria since 6 Apr 2010
  • Croatia since 6 Apr 2010
  • Cyprus since 6 Apr 2010
  • Czechia since 6 Apr 2010
  • Denmark since 6 Apr 2010
  • Estonia since 6 Apr 2010
  • Finland since 6 Apr 2010
  • France since 6 Apr 2010
  • Germany since 6 Apr 2010
  • Greece since 6 Apr 2010
  • Hungary since 6 Apr 2010
  • Ireland since 6 Apr 2010
  • Italy since 6 Apr 2010
  • Latvia since 6 Apr 2010
  • Lithuania since 6 Apr 2010
  • Luxembourg since 6 Apr 2010
  • Malta since 6 Apr 2010
  • Netherlands since 6 Apr 2010
  • Poland since 6 Apr 2010
  • Portugal since 6 Apr 2010
  • Romania since 6 Apr 2010
  • Slovakia since 6 Apr 2010
  • Slovenia since 6 Apr 2010
  • Spain since 6 Apr 2010
  • Sweden since 6 Apr 2010

Last checked 23 Oct 2026.

Specification

EUDAMED

Device Name
Prontosan Wound Irrigation Solution
Model / Reference
400423
Primary DI / UDI-DI
04046963787271
Basic UDI-DI
40392390000009242S
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

  • Sterile
  • Incorporates Medicinal Product

Other properties (11)

  • 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