Skip to content

Burnshield

by Burnshield (Pty) Ltd 16 variants

Ref L550003

Burnshield (L550003) is a device classified as Class IIb (EU), Unclassified (US) made by Burnshield (Pty) Ltd, registered in EUDAMED on 24 Jun 2024 (Basic UDI-DI B-06007645000192), cleared under FDA 510(k) K943728 on 27 Sep 1994 and listed in FDA GUDID since 17 Dec 2018 (UDI-DI 06007645000192), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K943728

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06007645000192 Basic UDI-DI 06007645000192UDI-DIDate24 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06007645000192 UDI-DI Date17 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SN GUDID from GUDID Traditional NumberK943728 Date27 Sep 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06007645000192 registered 24 Jun 2024 Active
  • FDA 510(k) K943728 decided 27 Sep 1994 Active
  • FDA GUDID UDI-DI 06007645000192 listed 17 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K943728
  2. Listed FDA GUDID 06007645000192
  3. Registered EUDAMED B-06007645000192

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Burn gel
Device name
Burnshield Hydrogel Spray Bottle 125ml (4.5oz)
Model / Ref / Catalog
L550003 EUDAMED
550003 GUDID
Primary DI / UDI-DI
06007645000192
Basic UDI-DI
B-06007645000192
FDA product code
MGQ
EMDN code
M0408 Dressings for burns only
GMDN term
Burn gel
Device class
Class IIb EUDAMED
U GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 125 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
L550003
GUDID
550003
Device classEUDAMED
Class IIb
GUDID
U

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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
  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)