Skip to content

Burnshield 550008F

by Burnshield (Pty) Ltd

Ref L550008F

Burnshield 550008F is a device classified as Class IIb (EU), Unclassified (US) made by Burnshield (Pty) Ltd, registered in EUDAMED on 14 May 2026 (Basic UDI-DI B-06007645006354), cleared under FDA 510(k) K943728 on 27 Sep 1994 and listed in FDA GUDID since 17 Dec 2018 (UDI-DI 06007645006354), 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-06007645006354 Basic UDI-DI 06007645006354UDI-DIDate14 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06007645006354 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-06007645006354 registered 14 May 2026 Active
  • FDA 510(k) K943728 decided 27 Sep 1994 Active
  • FDA GUDID UDI-DI 06007645006354 listed 17 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K943728
  2. Listed FDA GUDID 06007645006354
  3. Registered EUDAMED B-06007645006354

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  • Withdrawn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

Trade name
Mundial EUDAMED
Burnshield GUDID
Generic name
Burn gel
Device name
Mundial Home / Travel Burn Kit
Model / Ref / Catalog
L550008F EUDAMED
550008F GUDID
Primary DI / UDI-DI
06007645006354
Basic UDI-DI
B-06007645006354
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

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
L550008F
GUDID
550008F
Device classEUDAMED
Class IIb
GUDID
U
Sterilise before useEUDAMED
Yes
GUDID
No
Contains latexEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 06007645006354: EUDAMED states Yes, FDA GUDID states No.
  • Contains latex UDI-DI 06007645006354: EUDAMED states Yes, FDA GUDID states No.

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.

Related devices

Category: Burn gelSynthetic polymer burn dressing, gel-coated

Cleared under the same submission (K943728)

and 6 more cleared under K943728

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 YesEUDAMEDNoGUDID
  • Single use
  • Contains latex YesEUDAMEDNoGUDID
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)