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TwinSheet4Glide
EUDAMEDClass I (EU MDR)
Ref IM150/140NModel Positioning HorizontalRef IM4315Ref IM4317
Identity
- Trade Name
- TwinSheet4Glide EUDAMED
- Device Name
- TwinSheet4Glide EUDAMED
- Model / Reference
- Positioning Horizontal EUDAMEDIM150/140N EUDAMEDIM4315 EUDAMEDIM4317 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708012512041 EUDAMED05708012002559 EUDAMED05708012002849 EUDAMED
- Basic UDI-DI
- 57080121006LU 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
TwinSheet4Glide 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 | 57080121006LU | Class I | Active |
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Manufacturer
- Manufacturer
- Etac Immedia A/S
- EUDAMED SRN
- DK-MF-000019241
Sources (3)
- EUDAMED 45d58495-dd34-4088-9cce-fe0fc2dcb45e 61 fields · synced Jul 22, 2026
- EUDAMED ea6069f7-b6e4-43aa-a053-c467933b7450 61 fields · synced May 17, 2026
- EUDAMED e89d4ca2-9454-445b-88d0-b434239a5da9 61 fields · synced May 18, 2026