Identity
- Device Name
- Ventilation Seat Cushion EUDAMED
- Model / Reference
- SW6412 EUDAMEDSW6412A111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850082804085 EUDAMED
- Basic UDI-DI
- 0850082804A0004DQ EUDAMED
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Ventilation Seat Cushion by Changsha Anxiang Medical Technology 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 | 0850082804A0004DQ | Class I | Active |
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Manufacturer
- Manufacturer
- Changsha Anxiang Medical Technology Co., LTD
- EUDAMED SRN
- CN-MF-000045942
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 049c4f28-0543-4ad7-983c-571a2dd16443 61 fields · synced Jun 20, 2026