Identity
- Trade Name
- In2Sheet EUDAMEDImmedia FDA UDI
- Generic Name
- Patient transfer sliding mat FDA UDI
- Device Name
- In2Sheet EUDAMED
- Model / Reference
- Positioning Horizontal EUDAMEDIM4128 EUDAMEDIn2Sheet w/handles midi FDA UDI
Identifiers
- Catalog Number
- IM4128 FDA UDI
- Primary DI / UDI-DI
- 05708012002313 EUDAMEDFDA UDI
- Basic UDI-DI
- 57080121004LQ EUDAMED
- FDA Product Code
- IKX FDA UDI
- EMDN Code
- Y122799 NON-MOTORIZED VEHICLES AND MEANS OF TRANSPORT - OTHER EUDAMED
- GMDN Term
- Patient transfer sliding mat FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
In2Sheet by Etac Immedia A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57080121004LQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Etac Immedia A/S
- EUDAMED SRN
- DK-MF-000019241
Sources (2)
- EUDAMED a13e808a-e7d1-40a9-89ca-417e96398ca4 61 fields · synced Jun 19, 2026
- FDA UDI 622f159b-df1f-403e-953c-afd7b43a7008 33 fields · synced May 30, 2026