Identity
- Trade Name
- SatinSheet EUDAMED
- Device Name
- SatinSheet EUDAMED
- Model / Reference
- Positioning Horizontal EUDAMEDIM4256S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708012558896 EUDAMED
- Basic UDI-DI
- 57080121001LJ EUDAMED
- EMDN Code
- Y122799 NON-MOTORIZED VEHICLES AND MEANS OF TRANSPORT - 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
SatinSheet 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 | 57080121001LJ | Class I | Active |
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Manufacturer
- Manufacturer
- Etac Immedia A/S
- EUDAMED SRN
- DK-MF-000019241
Sources (1)
- EUDAMED 2a19d875-fe83-4f98-8aba-951467984fed 61 fields · synced Jun 19, 2026