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Brustop

by Burnshield (Pty) Ltd 2 variants

Ref B550095

Brustop (B550095) is a Class IIb device made by Burnshield (Pty) Ltd, registered in EUDAMED on 25 Jun 2024 (Basic UDI-DI B-08057438195084), active as of 22 Oct 2026.

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08057438195084 Basic UDI-DI 08057438195084UDI-DIDate25 Jun 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Brustop Hydrogel Bottle 50ml (1.8oz)
Model / reference
B550095
Primary DI / UDI-DI
08057438195084
Basic UDI-DI
B-08057438195084
EMDN code
M0408 Dressings for burns only
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
ZA-MF-000018376
Authorised representative
Burnshield Europe B.V. NL-AR-000014621

Similar devices in this category

Other devices filed under DRESSINGS FOR BURNS ONLY.

Other devices from Burnshield (Pty) Ltd

See all devices from Burnshield (Pty) Ltd →

Properties

  • Supplied sterile
Other properties (11, all answered No)