Identity
- Trade Name
- Solace Scottature EUDAMED
- Device Name
- Solace Scottature Hydrogel Spray Bottle 125ml (4.5oz) EUDAMED
- Model / Reference
- SS550097 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057438194902 EUDAMED
- Basic UDI-DI
- B-08057438194902 EUDAMED
- EMDN Code
- M0408 DRESSINGS FOR BURNS ONLY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Solace Scottature 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-08057438194902 | 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 (1)
- EUDAMED 0e61686f-0f02-4a81-90bd-04c2214f771b 61 fields · synced Jun 17, 2026