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Air Supply
EUDAMEDFDA UDIClass I (EU MDR)
Ref HTAIR2300Model Lateral Transfer Device
Identity
- Trade Name
- Air Supply EUDAMEDHoverTech Air Supply FDA UDI
- Generic Name
- Medical device air compressor FDA UDI
- Device Name
- 230V, 50Hz HTAIR HoverTech Air Supply FDA UDI
- Model / Reference
- Lateral Transfer Device EUDAMEDHTAIR2300 EUDAMEDFDA UDI
- Description
- 230V, 50Hz HTAIR HoverTech Air Supply FDA UDI
Identifiers
- Catalog Number
- HTAIR2300 FDA UDI
- Primary DI / UDI-DI
- 00816299011241 EUDAMEDFDA UDI
- Basic UDI-DI
- 081629901ASSC EUDAMED
- FDA Product Code
- FRZ FDA UDIFNG FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Medical device air compressor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6775 FDA UDI880.5500 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Air Supply 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 | 081629901ASSC | 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 be117b41-cc4a-4225-a588-1fb72627b2c9 61 fields · synced May 30, 2026
- FDA UDI 22002613-0804-4e8a-a1e0-6ad14f37b15f 36 fields · synced May 30, 2026