Identity
- Trade Name
- LIBRAII EUDAMED
- Device Name
- Alternating-pressure bed mattress system EUDAMED
- Model / Reference
- Libra-II + Effect 5000 EUDAMEDLIBRAII EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972910603996 EUDAMED
- Basic UDI-DI
- B-16972910603996 EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
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
Libraii by Airflo (Xiamen) Medical Co., Ltd — Class IIa — 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-16972910603996 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Airflo (Xiamen) Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000008552
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 9d2f2166-6d7a-460d-97ed-6df4b73b5613 61 fields · synced Jul 27, 2026