Identity
- Trade Name
- Maxi Twin EUDAMEDFDA UDI
- Generic Name
- Mobile patient lifting system, electrically-powered FDA UDI
- Device Name
- SARA FLEX EUDAMEDMaxi Twin Dedicated Loop Medium - Mobile Floor Lifter - Safe working load of 400 lb / 182 kg. FDA UDI
- Model / Reference
- HEB0000 EUDAMEDKTBB2ESX2WW EUDAMEDFDA UDI
- Description
- Maxi Twin Dedicated Loop Medium - Mobile Floor Lifter - Safe working load of 400 lb / 182 kg. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055982787055 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520112VK EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- V0805030102 ELECTRIC MOBILE LIFTS EUDAMED
- GMDN Term
- Mobile patient lifting system, electrically-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5510 FDA UDI
- Market of Registration
- Austria 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
Yes
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
Maxi Twin by Arjohuntleigh AB — 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 | 5060693520112VK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED b158f46d-3af2-47d9-92bf-6d8fbf5c755e 61 fields · synced Jun 20, 2026
- FDA UDI bc7d7c99-37ed-47fd-98b6-d45b14b9afe7 33 fields · synced May 27, 2026