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PositioningWedge
EUDAMEDClass I (EU MDR)
Ref IM53/80NSModel Positioning CushionsRef IM5300NS
Identity
- Trade Name
- PositioningWedge EUDAMED
- Device Name
- PositioningWedge EUDAMED
- Model / Reference
- Positioning Cushions EUDAMEDIM53/80NS EUDAMEDIM5300NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708012363193 EUDAMED05708012389582 EUDAMED
- Basic UDI-DI
- 57080128002N5 EUDAMED
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
PositioningWedge by Etac Immedia A/S — 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 | 57080128002N5 | Class I | Active |
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Manufacturer
- Manufacturer
- Etac Immedia A/S
- EUDAMED SRN
- DK-MF-000019241
Sources (2)
- EUDAMED ad5723ae-35e4-4f39-b05e-89c2f3725829 61 fields · synced Jul 12, 2026
- EUDAMED ade0bca6-db03-4756-8ac5-231ef5b0f1c5 61 fields · synced May 18, 2026