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Sara Plus standing sling – extra postural support
EUDAMEDFDA UDIClass I (EU MDR)
Ref KKA5370-LModel KKX522900L
Identity
- Trade Name
- Sara Plus standing sling – extra postural support EUDAMEDSARA PLUS FDA UDI
- Generic Name
- General-purpose patient lifting system sling/harness FDA UDI
- Device Name
- SLING - STANDING EUDAMEDSara Plus EPS Sling - L FDA UDI
- Model / Reference
- KKX522900L EUDAMEDKKA5370-L EUDAMEDFDA UDI
- Description
- Sara Plus EPS Sling - L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055982799034 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520150VT EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- V0805038002 NON-RIGID SUPPORTS FOR LIFTS (HARNESSES) EUDAMED
- GMDN Term
- General-purpose patient lifting system sling/harness 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
Sara Plus standing sling – extra postural support 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 | 5060693520150VT | 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 71738efe-0b7a-471b-895b-51465cac26b9 61 fields · synced Jul 28, 2026
- FDA UDI db599806-363f-4573-8db7-7ed3b8d00be2 33 fields · synced May 29, 2026