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Burnshield 901001

by Burnshield (Pty) Ltd

Ref L901001

Burnshield 901001 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-06007645001410), cleared under FDA 510(k) K943728 on 27 Sep 1994 and listed in FDA GUDID since 1 Nov 2018 (UDI-DI 06007645001410), 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-06007645001410 Basic UDI-DI 06007645001410UDI-DIDate24 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06007645001410 UDI-DI Date1 Nov 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-06007645001410 registered 24 Jun 2024 Active
  • FDA 510(k) K943728 decided 27 Sep 1994 Active
  • FDA GUDID UDI-DI 06007645001410 listed 1 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K943728
  2. Listed FDA GUDID 06007645001410
  3. Registered EUDAMED B-06007645001410

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  • Withdrawn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
Burnshield
Generic name
Synthetic polymer burn dressing, gel-coated
Device name
Burnshield Dressing 200mmx450mm (8"x18")
Model / Ref / Catalog
L901001 EUDAMED
901001 GUDID
Primary DI / UDI-DI
06007645001410
Basic UDI-DI
B-06007645001410
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 — 270 Gram
Width — 450 Millimeter
Length — 200 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
L901001
GUDID
901001
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.

Related devices

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