Identity
- Trade Name
- Comfort Plus EUDAMED
- Device Name
- Air cushion EUDAMED
- Model / Reference
- DM-645 EUDAMEDDM-845 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972910602060 EUDAMED06972910602084 EUDAMED
- Basic UDI-DI
- 697291060PRCSS EUDAMED
- Direct Marketing DI
- 06972910602060 EUDAMED06972910602084 EUDAMED
- EMDN Code
- V08030102 NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Comfort Plus by Airflo (Xiamen) Medical Co., Ltd — Class I — 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 | 697291060PRCSS | Class I | 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 (2)
- EUDAMED 46dea22e-7623-43c3-9578-744ab4a2e9ef 61 fields · synced Jul 15, 2026
- EUDAMED 3f4c220c-5934-4383-b930-b5e4a809b221 61 fields · synced May 18, 2026