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Sara Flex
EUDAMEDFDA UDIClass I (EU MDR)
Ref HEB2000-98Model KHA1010Ref HEB0000-36Model HEB0000Ref HEB2000-34Ref HEB2000-39Ref HEB0000-00Ref HEB2000-12Ref HEB0000-12Ref HEB2000-98-BERef HEB0000-98-BERef HEB0000-39Ref HEB0000-24Ref HEB0000-16Ref HEB0000-19Ref HEB0000-34Ref HEB0000-98Ref MFA3000Model KKX522900LRef HEB2000-40Ref HEB2000-08Ref HEB0000-45Ref HEB0000-17Ref HEB2000-17Ref HEB1000-00
Identity
- Trade Name
- Sara Flex EUDAMEDFDA UDISara Flex disposable standing sling EUDAMED
- Generic Name
- General-purpose patient lifting system sling/harness FDA UDI
- Device Name
- Tenor EUDAMEDSARA FLEX EUDAMEDSLING - STANDING EUDAMEDSara Flex disposable standing sling FDA UDI
- Model / Reference
- KHA1010 EUDAMEDHEB2000-98 EUDAMEDHEB0000 EUDAMEDHEB0000-36 EUDAMEDHEB2000-34 EUDAMEDHEB2000-39 EUDAMEDHEB0000-00 EUDAMEDHEB2000-12 EUDAMEDHEB0000-12 EUDAMEDHEB2000-98-BE EUDAMEDHEB0000-98-BE EUDAMEDHEB0000-39 EUDAMEDHEB0000-24 EUDAMEDHEB0000-16 EUDAMEDHEB0000-19 EUDAMEDHEB0000-34 EUDAMEDHEB0000-98 EUDAMEDKKX522900L EUDAMEDMFA3000 EUDAMEDFDA UDIHEB2000-40 EUDAMEDHEB2000-08 EUDAMEDHEB0000-45 EUDAMEDHEB0000-17 EUDAMEDHEB2000-17 EUDAMEDHEB1000-00 EUDAMED
- Description
- Sara Flex disposable standing sling FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056097315492 EUDAMED05059441151722 EUDAMED05056097346427 EUDAMED05059441219934 EUDAMED05056097327921 EUDAMED05056097346397 EUDAMED05056097341750 EUDAMED05059441220671 EUDAMED05059441220664 EUDAMED05059441219910 EUDAMED05059441139683 EUDAMED05056097341767 EUDAMED05059441219897 EUDAMED05056097342474 EUDAMED05056097315447 EUDAMED05055982788038 EUDAMEDFDA UDI05059441174912 EUDAMED05056097315478 EUDAMED05059441219903 EUDAMED05056097341774 EUDAMED05056097346403 EUDAMED05059441176220 EUDAMED
- Basic UDI-DI
- 5060693520082W3 EUDAMED5060693520112VK EUDAMED5060693520150VT 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 EUDAMEDGreece EUDAMEDDenmark EUDAMEDLatvia EUDAMEDPoland EUDAMEDBelgium EUDAMEDSlovakia EUDAMEDNorway EUDAMEDLithuania EUDAMEDRomania EUDAMEDIreland EUDAMEDSlovenia EUDAMEDCzechia 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sara Flex 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 (23)
- EUDAMED 20a07039-9fd0-4136-82f3-9b3cc2a4adb2 61 fields · synced Aug 3, 2026
- EUDAMED 3472f943-3ab4-412d-9c89-48f34764a685 61 fields · synced May 16, 2026
- EUDAMED cf7c2e24-ce2b-443f-9885-ff42a96c5376 61 fields · synced May 16, 2026
- EUDAMED 9a09f398-388e-4cb9-bc5c-124eee1c711c 61 fields · synced May 16, 2026
- EUDAMED 4ca7916a-9701-44a1-a3da-38995e678b94 61 fields · synced May 17, 2026
- EUDAMED 89fd6a33-f2c3-4d89-8a3a-c2a83a5944c6 61 fields · synced May 17, 2026
- EUDAMED ddf25867-59a7-43b7-8960-b2d5e4fbf938 61 fields · synced May 17, 2026
- EUDAMED a8d87c02-4933-40ae-a7f1-a14c78604ca9 61 fields · synced May 17, 2026
- EUDAMED 01870f01-e4c0-4891-b4c9-a9e8f4e7d0e5 61 fields · synced May 17, 2026
- EUDAMED 66ad214f-3dd3-495d-91bc-9fbc796288e0 61 fields · synced May 17, 2026
- EUDAMED 3eb6a560-64c6-4d3c-ae37-6d84e50bdfca 61 fields · synced May 17, 2026
- EUDAMED 67b8b69a-aeaa-4268-a7e9-7ecbf6665522 61 fields · synced May 17, 2026
- EUDAMED 7b082632-636a-40ea-969b-230516401623 61 fields · synced May 17, 2026
- EUDAMED 244bf123-29fe-441f-acb8-2017e57c5532 61 fields · synced May 17, 2026
- EUDAMED d084a18f-f86f-41c6-a495-53a1174fff0c 61 fields · synced May 17, 2026
- EUDAMED 3698f678-9241-4893-ab3c-5269ffa732c1 61 fields · synced May 17, 2026
- EUDAMED af67027f-b1c3-44ac-9767-8a7e5748d3a8 61 fields · synced May 18, 2026
- EUDAMED 7eeb76eb-d90c-48e5-a635-389367086d00 61 fields · synced May 18, 2026
- EUDAMED 3e4dcdd5-63c1-499f-817e-b8e4ecfcdba0 61 fields · synced May 18, 2026
- EUDAMED 46cdc770-acf6-45aa-9ebc-a58309cc30a1 61 fields · synced May 18, 2026
- EUDAMED 3bb5ac99-a924-49e6-abd2-f83dfe337e41 61 fields · synced May 18, 2026
- EUDAMED 1a89362f-bfca-4767-99cd-0e5960c19e35 61 fields · synced May 18, 2026
- FDA UDI 7b6d6ed6-e185-4576-9e80-d9bd9ada8224 33 fields · synced May 30, 2026