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Burnshield

by Burnshield (Pty) Ltd 16 variants

Ref L901007

Burnshield (L901007) 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-06007645001403), cleared under FDA 510(k) K943728 on 27 Sep 1994 and listed in FDA GUDID since 17 Dec 2018 (UDI-DI 06007645001403), 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-06007645001403 Basic UDI-DI 06007645001403UDI-DIDate24 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06007645001403 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-06007645001403 registered 24 Jun 2024 Active
  • FDA 510(k) K943728 decided 27 Sep 1994 Active
  • FDA GUDID UDI-DI 06007645001403 listed 17 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K943728
  2. Listed FDA GUDID 06007645001403
  3. Registered EUDAMED B-06007645001403

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  • Withdrawn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
Synthetic polymer burn dressing, gel-coated
Device name
Burnshield Dressing 600mmx400mm (24"x16")
Model / Ref / Catalog
L901007 EUDAMED
901007 GUDID
Primary DI / UDI-DI
06007645001403
Basic UDI-DI
B-06007645001403
FDA product code
MGQ
EMDN code
M0408 Dressings for burns only
GMDN term
Synthetic polymer burn dressing, gel-coated
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
Weight — 500 Gram
Width — 400 Millimeter
Length — 600 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
L901007
GUDID
901007
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)