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HoverMatt PROS - Slide Sheet
EUDAMEDFDA UDIClass I (EU MDR)
Ref PROS-SS-KIT-1Model Lateral Transfer Device
Identity
- Trade Name
- HoverMatt PROS - Slide Sheet EUDAMEDHoverMatt PROS FDA UDI
- Generic Name
- Patient transfer/turning sheet, single-use FDA UDI
- Device Name
- HoveMatt PROS Slide Sheet Kit Patient Repositioning Off-Loading System (Slide Sheet + HoverCover, + pair of wedges) FDA UDI
- Model / Reference
- Lateral Transfer Device EUDAMEDPROS-SS-KIT-1 EUDAMEDPROS-SS-KIT FDA UDI
- Description
- HoveMatt PROS Slide Sheet Kit Patient Repositioning Off-Loading System (Slide Sheet + HoverCover, + pair of wedges) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816299012781 EUDAMEDFDA UDI
- Basic UDI-DI
- 081629901SSU2 EUDAMED
- FDA Product Code
- FMR FDA UDI
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Patient transfer/turning sheet, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6785 FDA UDI
- Market of Registration
- Sweden 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
Yes
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
HoverMatt PROS - Slide Sheet by Hovertech International — 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 | 081629901SSU2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- HoverTech International
- EUDAMED SRN
- US-MF-000008435
- Authorised Representative
- Etac Supply Center AB SE-AR-000001601
Sources (2)
- EUDAMED 815c2e2b-3ba6-415e-b0d6-97f3e978ecf1 61 fields · synced Jun 19, 2026
- FDA UDI c76c4936-66e8-435d-9127-a4dc352d978b 33 fields · synced May 30, 2026