Identity
- Trade Name
- 9111-50 XXL EUDAMED
- Device Name
- STANDARD COMPRESSION BURNS GARMENT EUDAMED
- Model / Reference
- 9111-50 XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435353322691 EUDAMED
- Basic UDI-DI
- 84353533BURNSR3 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
This 9111-50 XXL device, manufactured by VOE , S.A., is a standard compression burns garment designed for the treatment of minor to moderate first-degree and second-degree burns. Its sterile, non-penetrating nature makes it ideal for use in clinical settings. The device features a basic ultrasound-diagnostic (basic UdI) capability and is intended for immediate use after burn injuries.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 84353533BURNSR3 | Class I | Active |
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Manufacturer
- Manufacturer
- Voe , S.a
- EUDAMED SRN
- ES-MF-000013290
Sources (1)
- EUDAMED 8bd6dc3f-a5e6-43d0-ab7b-55d55b25d815 61 fields · synced Jul 2, 2026