Identity
- Trade Name
- AXTAIR XXL EUDAMED
- Device Name
- AXTAIR EUDAMED
- Model / Reference
- AXTAIR EUDAMEDVAXT/XXL-120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664897033663 EUDAMED
- Basic UDI-DI
- 366489700083H9 EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Axtair Xxl by Winncare France — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 366489700083H9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Winncare France
- EUDAMED SRN
- FR-MF-000000482
Sources (1)
- EUDAMED 1732c2d5-b75a-47f4-b255-90e2fdbe14b1 61 fields · synced Jul 30, 2026