Identity
- Trade Name
- Pure Isla EUDAMED
- Device Name
- Pure shower chairs EUDAMED
- Model / Reference
- 1654617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04028698135732 EUDAMED
- Basic UDI-DI
- 4028698PureChairP9 EUDAMED
- EMDN Code
- Y091203 CHAIRS, TOILET AND SHOWER 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
Pure Isla by Invacare GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 4028698PureChairP9 | Class I | Active |
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Manufacturer
- Manufacturer
- Invacare GmbH
- EUDAMED SRN
- DE-MF-000006985
Sources (1)
- EUDAMED 59cb9380-bd82-4f80-b908-954ca13dac96 61 fields · synced Jun 19, 2026