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Sara Plus
EUDAMEDFDA UDIClass I (EU MDR)
Ref HEP1001Model KHA1010Ref HEP2001-UKRef KKA5120-MModel KKX522900LRef HEP0001-UKModel HEB0000
Identity
- Trade Name
- Sara Plus EUDAMEDFDA UDISara Plus standing sling EUDAMED
- Generic Name
- General-purpose patient lifting system sling/harness FDA UDI
- Device Name
- Tenor EUDAMEDSLING - STANDING EUDAMEDSARA FLEX EUDAMEDSara Plus standing sling - M FDA UDI
- Model / Reference
- KHA1010 EUDAMEDHEP1001 EUDAMEDHEP2001-UK EUDAMEDKKX522900L EUDAMEDKKA5120-M EUDAMEDFDA UDIHEB0000 EUDAMEDHEP0001-UK EUDAMED
- Description
- Sara Plus standing sling - M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055982787437 EUDAMED05055982787475 EUDAMED05055982798891 EUDAMEDFDA UDI05055982787413 EUDAMED
- Basic UDI-DI
- 5060693520082W3 EUDAMED5060693520150VT EUDAMED5060693520112VK EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- V0805030102 ELECTRIC MOBILE LIFTS EUDAMEDV0805038002 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 EUDAMEDIreland EUDAMEDNorthern Ireland 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
Yes
EUDAMEDEUDAMED
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 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 | 5060693520082W3 | 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 (5)
- EUDAMED 0a8a95ee-051f-4382-af5e-ec0024a4de03 61 fields · synced Aug 3, 2026
- EUDAMED 62d934dd-426e-46cc-af1c-8bd368093c98 61 fields · synced May 18, 2026
- EUDAMED 5caf8f21-2baa-4799-99d8-100594fcdcd3 61 fields · synced May 18, 2026
- EUDAMED 60844448-b4a0-42e2-8d97-0dc768a1c260 61 fields · synced May 19, 2026
- FDA UDI 5aadabc0-f1fb-45b8-92d1-a53c3b47b6bc 33 fields · synced May 30, 2026