Identity
- Trade Name
- ISA™ COMPACT EUDAMEDInvacare ISA Lift FDA UDI
- Generic Name
- Mobile patient lifting system, electrically-powered FDA UDI
- Device Name
- ISA EUDAMEDINVACARE ISA COMPACT STAND-UP LIFT FDA UDI
- Model / Reference
- ISACOMPACT EUDAMEDFDA UDI
- Description
- INVACARE ISA COMPACT STAND-UP LIFT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05600494138712 EUDAMEDFDA UDI
- Basic UDI-DI
- 5600494ISACZ 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
- Portugal 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
Isa™ Compact by Invacare Portugal, Unipessoal Lda. — 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 | 5600494ISACZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invacare Portugal, Unipessoal Lda.
- EUDAMED SRN
- PT-MF-000006551
Sources (2)
- EUDAMED 7aac6712-f746-4d06-8349-a6cfdbe3063a 61 fields · synced Jul 14, 2026
- FDA UDI 5757384b-78b7-46ef-86ef-3851cedd56dc 34 fields · synced May 30, 2026