Identity
- Trade Name
- Derminor EUDAMED
- Device Name
- Derminor Burn Sachet 3.5ml (1/8oz) EUDAMEDDerminor Hydrogel Tube 25ml (0.85oz) EUDAMED
- Model / Reference
- N550216 EUDAMEDN550110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435232365290 EUDAMED08435232363449 EUDAMED
- Basic UDI-DI
- B-08435232365290 EUDAMEDB-08435232363449 EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Derminor 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08435232365290 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Burnshield (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000018376
- Authorised Representative
- Burnshield Europe B.V. NL-AR-000014621
Sources (2)
- EUDAMED e53024e3-2e68-4019-8a80-fecbde5bc06d 61 fields · synced Jul 17, 2026
- EUDAMED 55406bcd-163b-4913-9ee3-18db94eb39f6 61 fields · synced May 16, 2026