Identity
- Device Name
- Cushion EUDAMED
- Model / Reference
- Inflatable,foam EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701101500938 EUDAMED
- Basic UDI-DI
- 37011015PHARWR2025DB EUDAMED
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Cushion by Ningbo Unico Products 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 | 37011015PHARWR2025DB | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Unico Products Co., Ltd
- EUDAMED SRN
- CN-MF-000039604
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (2)
- EUDAMED 87f4d78d-605f-46f8-a1df-e8bf2e263d2f 61 fields · synced Jul 12, 2026
- EUDAMED 87f4d78d-605f-46f8-a1df-e8bf2e263d2f-1 61 fields · synced Jun 10, 2026