Identity
- Trade Name
- I-Fit 9780E EUDAMED
- Device Name
- I-Fit EUDAMED
- Model / Reference
- 9780E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04028698100495 EUDAMED
- Basic UDI-DI
- 4028698I-FitVN EUDAMED
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Hydrotherapy bath/tank
I-Fit 9780E by Invacare GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4028698I-FitVN | Class I | Active |
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Manufacturer
- Manufacturer
- Invacare GmbH
- EUDAMED SRN
- DE-MF-000006985
Sources (1)
- EUDAMED 412f8740-3eaa-4402-a8cb-082b72a428be 61 fields · synced Jul 28, 2026