Identity
- Trade Name
- Q2Roller EUDAMEDQ2 Roller Lateral Turning Device FDA UDI
- Generic Name
- Patient transfer system, manual FDA UDI
- Device Name
- Q2Roller w/ 5 pack of chux FDA UDI
- Model / Reference
- Positioning Device EUDAMEDHTR-200 EUDAMEDHTR-200-1Roller FDA UDI
- Description
- Q2Roller w/ 5 pack of chux FDA UDI
Identifiers
- Catalog Number
- HTR-200-1Roller FDA UDI
- Primary DI / UDI-DI
- 00816299011678 EUDAMEDFDA UDI
- Basic UDI-DI
- 081629901PDST EUDAMED
- FDA Product Code
- FMR FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Patient transfer system, manual 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 44 Inch FDA UDI
Q2Roller 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 | 081629901PDST | 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 965c2ce1-7a92-4288-a327-942b7f543679 61 fields · synced Jul 9, 2026
- FDA UDI 139ad5e1-8e7a-416f-94ed-211440dbc4c1 36 fields · synced May 30, 2026