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Mediburn

EUDAMED

Class IIb (EU MDR)

Ref M750075Ref M750050Ref M750010Ref M750065

by Burnshield (Pty) Ltd

Identity

Trade Name
Mediburn EUDAMED
Device Name
Mediburn Hydrogel Spray 50ml (1.8oz) EUDAMED
Mediburn Burn Sachet 3.5ml (1/8oz) EUDAMED
Mediburn Dressing 200mm x 200mm (8"x8") EUDAMED
Mediburn Hydrogel Spray 125ml (4.5oz) EUDAMED
Model / Reference
M750075 EUDAMED
M750050 EUDAMED
M750010 EUDAMED
M750065 EUDAMED

Identifiers

Primary DI / UDI-DI
06007645009096 EUDAMED
06007645009058 EUDAMED
06007645008983 EUDAMED
06007645009072 EUDAMED
Basic UDI-DI
B-06007645009096 EUDAMED
B-06007645009058 EUDAMED
B-06007645008983 EUDAMED
B-06007645009072 EUDAMED
EMDN Code
M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
M04040602 POLYURETHANE DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Mediburn by Burnshield (pty) Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Burnshield (Pty) Ltd
EUDAMED SRN
ZA-MF-000018376
Authorised Representative
Burnshield Europe B.V. NL-AR-000014621

Sources (4)

  • EUDAMED f857ee32-a03f-4ecc-9506-2281c330359e 61 fields · synced Jul 31, 2026
  • EUDAMED d24062e4-4896-443d-9da7-f0731e6d07ce 61 fields · synced May 17, 2026
  • EUDAMED 52488c2b-9574-40db-97c8-4adaa46f5c83 61 fields · synced May 18, 2026
  • EUDAMED ff214497-21c1-4633-8246-7304a738aa6e 61 fields · synced May 19, 2026