Skip to content

Medisafe

by Burnshield (Pty) Ltd

Ref 194429Model Medisafe

Medisafe (194429) is a Class IIb device made by Burnshield (Pty) Ltd, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-03701756311194), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03701756311194 Basic UDI-DI 03701756311194UDI-DIDate26 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Medisafe Burn Sachet 3.5ml (1/8oz)
Model / reference
Medisafe, 194429
Primary DI / UDI-DI
03701756311194
Basic UDI-DI
B-03701756311194
EMDN code
M0408 Dressings for burns only
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
France

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
  • Sterilise before use
Other properties (10, all answered No)