HoverMatt PROS - Air
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- HoverMatt PROS - Air EUDAMEDHoverMatt PROS FDA UDI
- Generic Name
- Inflatable patient transfer sliding mattress, reusable FDA UDI
- Device Name
- HoverMatt PROS Kit Patient Repositioning Off-Loading System (Air Matt + HoverCover + pair of wedges) FDA UDI
- Model / Reference
- Lateral Transfer Device EUDAMEDPROS-HM-KIT-1 EUDAMEDPROS-HM-KIT FDA UDI
- Description
- HoverMatt PROS Kit Patient Repositioning Off-Loading System (Air Matt + HoverCover + pair of wedges) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816299012804 EUDAMEDFDA UDI
- Basic UDI-DI
- 081629901HMSM EUDAMED
- FDA Product Code
- FRZ FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Inflatable patient transfer sliding mattress, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6775 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
HoverMatt PROS - Air by Hovertech International — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081629901HMSM | 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 0bc23908-4600-4cad-8ec0-52b49867407b 61 fields · synced Jul 9, 2026
- FDA UDI 36dd9da9-8c04-461f-8429-70b90ea59d9c 33 fields · synced May 30, 2026