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Derminor

by Burnshield (Pty) Ltd 2 variants

Ref N550216, N550110

Derminor (N550216) is a Class IIb device made by Burnshield (Pty) Ltd, registered in EUDAMED on 26 Nov 2025 (Basic UDI-DI B-08435232365290), 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-08435232365290 Basic UDI-DI Date26 Nov 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Derminor Burn Sachet 3.5ml (1/8oz)
Derminor Hydrogel Tube 25ml (0.85oz)
Model / reference
N550216, N550110
Primary DI / UDI-DI
08435232365290, 08435232363449
Basic UDI-DI
B-08435232365290, B-08435232363449
EMDN code
M04040501 Hydrogel dressings, non-combined
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Spain

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 HYDROGEL DRESSINGS, NON-COMBINED.

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)