Identity
- Trade Name
- RescueSheet EUDAMEDImmedia FDA UDI
- Generic Name
- Bed rescue sheet FDA UDI
- Device Name
- RescueSheet EUDAMED
- Model / Reference
- Special Solutions EUDAMEDIM108089 EUDAMEDRescueSheet - extra wide FDA UDI
Identifiers
- Catalog Number
- IM108089 FDA UDI
- Primary DI / UDI-DI
- 05708012002450 EUDAMEDFDA UDI
- Basic UDI-DI
- 57080126007MZ EUDAMED
- FDA Product Code
- IKX FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Bed rescue sheet 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
Category: Device sterilization/disinfection container, reusable
RescueSheet by Etac Immedia A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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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 | 57080126007MZ | 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 19e14512-10ea-48d2-a589-69d844883479 61 fields · synced Jun 20, 2026
- FDA UDI d2590cc0-4074-456c-bd87-53fc8a6a7d2e 33 fields · synced May 30, 2026