Identity
- Trade Name
- Biogaze EUDAMED
- Device Name
- Biogaze Hydrogel Tube 25ml (0.85oz) EUDAMEDBiogaze Hydrogel Spray Bottle 125ml (4.5oz) EUDAMEDBiogaze Hydrogel Burn Sachet 3.5ml (1/8oz) EUDAMED
- Model / Reference
- BG550103 EUDAMEDBG550102 EUDAMEDBG550104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717154534900 EUDAMED08717154534894 EUDAMED08717154534917 EUDAMED
- Basic UDI-DI
- B-08717154534900 EUDAMEDB-08717154534894 EUDAMEDB-08717154534917 EUDAMED
- EMDN Code
- M0408 DRESSINGS FOR BURNS ONLY 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
Biogaze 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-08717154534900 | 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 (3)
- EUDAMED 1becd5c1-1316-4a6c-8720-1ea0d113f4c1 61 fields · synced Aug 1, 2026
- EUDAMED 2ec5f9c1-885c-4d89-b8cf-65b1107ac69e 61 fields · synced May 17, 2026
- EUDAMED a5de0d9d-24e9-46b8-a5b3-2acf70af303e 61 fields · synced May 18, 2026